Reported Mar 14, 2018 · Terminated
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging…
Stryker 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: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile
- Includes the followinga. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620)
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 025007060007613327061499UDI 07613327061499 — Lot No. 17284FG2, 17291FG2, 17300FG2; b. 025007062007613327061659UDI 07613327061659 — Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2 - Amount recalled
- 60,753 units total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
This product could cause temporary or reversible health problems — stop using it.
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