Boston Scientific Corporation: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M0051340

Hazard

Potential for breach in sterile barrier of device packaging.

Details from the source

Reason for recall: Potential for breach in sterile barrier of device packaging. 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. Quantity: 5,020 (US); 20,770 (OUS) Lot/code info: 1. Outer Box UPN: M00513401. Inner Box UPN: M00513400. GTIN: 08714729777960. Lot Number: 38508541. 2. Outer Box UPN: M00513402. Inner Box UPN: M00513400. GTIN: 08714729778028. Lot Numbers: 38517807. 3. Outer Box UPN: M00513411. Inner Box UPN: M00513410. GTIN: 08714729777984. Lot Number: 38488064.

UPC codes

08714729777960, 08714729778028, 08714729777984

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.