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CER-SUB-1111-OT-BNT

RANFAC CORP. · Model 11GA X 11CM · UDI-DI 00850023741196

FGY Prescription
2
510(k) clearances
74
Adverse events (2 deaths)
7
Recalls
82
Facilities

Description

Cervos 11GA X 11" Delivery Cannula, Open Tip, With Blunt Stylet P/N: 74383-01M Customer #: 12153

Recalls

DateFirmReason
2022-07-29Hobbs Medical, Inc.Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration
2015-01-23Biologic Therapies, IncDevices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
2015-01-23Biologic Therapies, IncDevices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
2015-01-23Biologic Therapies, IncDevices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
2013-11-26Becton Dickinson & CompanyBD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely imp
2013-05-14Maquet Cardiovascular Us Sales, LlcThe specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
2005-10-31Wilson-Cook Medical IncMisbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.