Potential packaging breaches of inner blister and outer sterile blister.
Reason for recall: Potential packaging breaches of inner blister and outer sterile blister. Distribution: Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan. Quantity: 132 units (US); 26 units (OUS) Lot/code info: Part No. 5531-G-310-E; GTIN: 07613327390544; Lot No. 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, YW30KL; Expiration Date: 10/07/2028.
07613327390544
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.