Reported Aug 8, 2018 · Terminated
Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia.…
Arrow International 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: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.
- Lot codes and dates
- Lot/Batch Number13F18A0037
- Expiration Date/Expected LifeApr 2019
- Amount recalled
- 60 units
Where it was sold
Why it was recalled
Product contains dry natural rubber latex. Label states Latex Free.
This product could cause temporary or reversible health problems — stop using it.
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