ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 488 5-packs of ROTAWIRE Drive Extra Support devices distributed in the US, its territories, Japan, and Canada because the pouch seals may be open, which compromises the sterility of the products. The affected devices are identified by UPN H74939463005 for the 5-pack and UPN H74939463001 for individual units within the 5-pack, with batch numbers 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970, 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767.
The recall source does not specify what consumers should do in response to this recall.
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: 488 5-packs Lot/code info: ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.