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8,792 catalysts · 3,189 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
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8,792 catalysts · 3,189 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 584 earnings
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56 — Reason: Lack of Assurance of Sterility — Status: Ongoing
Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. — Reason: Defective Delivery System: Missing or duplicated needles within the injection kit — Status: Ongoing
Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11 — Reason: cGMP deviations — Status: Ongoing
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 100mg Anastrozole 4mg , 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4104-32 — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32. — Reason: Presence of Foreign substance - potential presence of metal particulate matter — Status: Ongoing
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: NBC. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: MEG. Advisory committee: General Hospital. Type: Traditional
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: OWE. Advisory committee: PA. Decision: OK30
Supplement type: Real-Time Process. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: SFJ. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: SDQ. Advisory committee: GU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PNK. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Advisory committee: PA. Decision: OK30
XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. — Reason: Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. — Status: Ongoing
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc, — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. — Reason: Due to adapter not being properly aligned or locked in place. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc) — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014). — Reason: Increased risk of purge leaks with Generation 1 purge cassettes. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Cub Pediatric Crib, Model FL19H — Reason: Cribs sold in the USA are missing two access door warning labels. — Status: Ongoing
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No — Reason: Due to product exhibiting potential to generate either invalid or false negative results. — Status: Ongoing
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd — Reason: If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property. — Status: Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc — Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. — Status: Ongoing
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. — Reason: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use. — Status: Ongoing
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package — Reason: Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals. — Status: Ongoing
Sterile Radiology Procedure Kits, Model Number DYNDH1491B — Reason: There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. — Status: Ongoing