Reported Dec 23, 2020 · Terminated
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF…
Galt Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137
Is this the product you have?
Centeze Centesis Catheter6F10cm18Ga12cmREF DRC-002-06 Centeze Centesis Catheter6F10cm18Ga12cmREF DRC-006-16
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published DRC-002-06Lot Numbers/UDI Code: 20108509/(01)0084 1268 100398(17)240428(10)20108509 20139676/(01)0084 1268 100398(11)200520(17)240519(10)20139676 20148911/(01)0084 1268 100398(11)200609(17)240608(10)20148911 20160253/(01)0084 1268 100398(11)200707(17)240706(10)20160253 20189100/(01)0084 1268 100398(11)200821(17)240820(10)20189100 Updated Information provided 03/16/2021: For additional DRC-006-16Lot Numbers: -20080351 -20234573 -20297230 -21008452 Additional Products — Lot Numbers: -20217235 -20217236 -20217237 - Amount recalled
- 9,920 catheters (updated on 03/17/2021)
Where it was sold
Why it was recalled
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
This product could cause temporary or reversible health problems — stop using it.
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