Reported Apr 4, 2018 · Terminated
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano…
Cook Inc.
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: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
G19182 | SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global |
G24215 | Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global |
G18740 | Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global |
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published K-J-SMS-571800Lot Number: 6802704, Expiration Date: 3/10/2019 K-JETS-551910-LLot Number: NS6360603, Expiration Date: 11/15/2018 K-JETS-7019-SIVFLot Number: 6503675, Expiration Date: 2/2/2019 - Amount recalled
- 473
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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