MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation removed certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters from the market due to incorrect labeling and packaging. A total of 63 devices were affected and distributed nationwide across 27 U.S. states, Puerto Rico, and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, the Netherlands, Poland, Switzerland, and other locations. The recalled products include two specific lot codes with expiration dates of January 4, 2023.
The recall record does not specify a remedy or recommended course of action for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Reason for recall: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. Distribution: Distributed nationwide to AL, AR, AZ, CO, FL, GA, IA, IL, KY, LA, MI, MN, MO, MS, NC, ND, NV, NY, OK, OH, PR, SC, TN, VA, WA, WI and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Switzerland Quantity: 63 devices Lot/code info: MAMBA 135 CM US microcatheter: UPN: H7493928713500; Batch: 26578155; GTIN: 8714729940241; and Expiration Date: 4-Jan-23 MAMBA 135 CM OUS microcatheter: UPN: H7493928713520; Batch: 26578465; GTIN: 8714729940265; and Expiration Date: 4-Jan-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.