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13,657 catalysts · 3,603 8k filing · 2,401 grant · 2,111 approval · 1,455 device 510k · 1,084 device recall · 1,000 device adverse event
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13,657 catalysts · 3,603 8k filing · 2,401 grant · 2,111 approval · 1,455 device 510k · 1,084 device recall · 1,000 device adverse event
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DR / mL W/ EXT SET; Catalog Number: 490208. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15DR, CARESITE LAD, 130 IN; Catalog Number: 477002. 2. IV ADMIN SET 85 IN.; Catalog Number: 477017. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 128 IN.; Catalog Number: 480231. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 60 DROPS/ML,141 in.; Catalog Number: 490349. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 134 IN.; Catalog Number: 490477. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. ET08US EXTENSION SET W/ULTRA Y SITE; Catalog Number: 474912. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 5CARESITE 1 ULRAPORT, 141 IN; Catalog Number: 490067. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET,2 CARESITE, TRIP MANIFOLD; Catalog Number: 490343. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: NOVUGEN. Form: TABLET. Route: ORAL
Product code: KWT. Advisory committee: Orthopedic. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: PLA. Advisory committee: Cardiovascular. Type: Traditional
Product code: JMT. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: ESW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: ESW. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: NVZ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOK. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 — Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. — Status: Ongoing
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare. — Reason: Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy. — Status: Ongoing
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 — Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. — Status: Ongoing
FlexLab (FLX); Version: FLX-217-40; — Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes — Status: Ongoing
FlexLab (FLX); Version: FLX-217-10; — Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes. — Status: Ongoing
Sponsor: CHARTWELL RX. Form: FOR SOLUTION. Route: ORAL
Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL
Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional