Reported Apr 26, 2017 · Ongoing
PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes…
CP Medical 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: CP Medical Inc · 1775 Corporate Dr Ste 150 · Norcross, GA · 30093-2960
Is this the product you have?
- PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
- Lot codes and dates
Lot Numbers - 150323-04150324-04150520-10150615-01150616-08150709-01151229-64160414-69160510-59160617-52160824-50
- Amount recalled
- 504 boxes/12 sutures - 6,048 individual sutures
Where it was sold
Why it was recalled
The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.
This product could cause temporary or reversible health problems — stop using it.
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