Boston Scientific Radial Jaw 4 forceps recalled for packaging risk
Boston Scientific is recalling certain Radial Jaw 4 Jumbo Biopsy Forceps (240cm) because the packaging may not keep the device sterile. The affected lot is 38496094, sold in US nationwide distribution, with international distribution still pending. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- Check inventory for lot 38496094 and UPNs M00513363 or M00513360.
- Do not use units with damaged, opened, or compromised packaging.
- Follow your facility's recall procedures and contact Boston Scientific for guidance.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 5,020 (US); 20,770 (OUS)
- Illnesses reported
- None reported
- Manufactured in
- 100 Boston Scientific Way, Marlborough, MA, United States
- Classification
- Class II
- Recall number
- Z-2840-2026
In the FDA's words
- Description
- Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360. Potential for breach in sterile barrier of device packaging. Outer Box UPN: M00513363; Inner Box UPN: M00513360. GTIN: 08714729761914. Lot Number: 38496094. Distribution: US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MN, MO, MS, MT, NC, NJ, NM, NY, OH, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI and International distribution pending. Affected quantity: 5,020 (US); 20,770 (OUS)
- Hazard
- Potential for breach in sterile barrier of device packaging.
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