Reported Nov 6, 2019 · Ongoing
Various products which were contract sterilized.
Anewmed 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: Anewmed Corporation · 2177 Flintstone Dr Ste O · Tucker, GA · 30084-5000
Is this the product you have?
- Various products which were contract sterilized.
- Lot codes and dates
332 of 332 products
Products covered by this recall # Product as published 1 G26862 (W3915653) 2 8065751801 (15027297X-2015-06) 3 E7924 (HD1206703) 4 MCFK64 (MBKY190) 5 PCB502090 (16105672, 17525844) 6 PCB602090 (17766962, 17716501, 17505067, 17465154, 17339717, 17191941, 16536005, 15473410, 15441264, 16685888) 7 PCB702090 (16722293) 8 277-10-50 (12094017) 9 420024 (73B1500332) 10 160636 (1202143, 1109213) 11 160656 (1208163) 12 7210424 (50506601) 13 AD750-KE40 (169-16), AD750-KE35 (182-16) 14 AD750-KE30 (102-16) 15 AD750-KE35 ( 118-16) 16 614-481 (648221) 17 76353200M (208992282, 207180152, 206969148, 206110579) 18 ASHA4250-01 (2004847) 19 GN1000 (9592565) 20 GN1500 (9916746) - Amount recalled
- 1,749 devices
Where it was sold
Why it was recalled
The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.
This product could cause temporary or reversible health problems — stop using it.
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