ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 433 5-packs of ROTAWIRE Drive and wireClip Torquer and ROTAWIRE Drive Floppy devices distributed in the US, its territories, Japan, and Canada. The devices were recalled because their pouch seals may be open, which could compromise the sterility of the products. The affected products are identified by UPN H74939462005 for the 5-pack and UPN H74939462001 for individual units, with batch numbers 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019, 27756205, 27756933, and 27756935.
The recall notice does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Pouch seals may be open, compromising sterility.
Reason for recall: Pouch seals may be open, compromising sterility. Distribution: Distribution in the US and territories, Japan, and Canada Quantity: 433 5-packs Lot/code info: ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.