MAMBA Flex 135 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 initiated a removal of 52 MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. The affected devices were distributed nationwide across 27 U.S. states and Puerto Rico, as well as internationally to eight countries including Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, and Switzerland. The recalled devices correspond to specific lot numbers (26578463 and 26578470) with an expiration date of January 4, 2023, and can be identified by UPN H7493928713540 US (Green) and GTIN 8714729940289.
The MAMBA Flex 135 Microcatheter is supplied with a protective sleeve over the catheter, sealed in a Tyvek pouch, and packaged in a carton with instructions for use and a closure strip. The source document does not specify a remedy or actions for affected consumers to take.
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: 52 devices Lot/code info: UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.