Stryker Corporation: Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL

Hazard

There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

Details from the source

Reason for recall: There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached. Distribution: US Nationwide distribution. Quantity: 182,344 total units Lot/code info: 5400-010-008I UDI-DI: 07613154340804, Lot Numbers: 2022100514 2023011113 2023012412 2023041712 2023052212 2023062714 2023110214 2024011112 2022100616 2023011612 2023012712 2023050812 2023053012 2023062914 2023110714 2024012912 2022101733 2023011712 2023021014 2023050912 2023061516 2023070314 2023111312 2024013112 2022101815 2023011912 2023021414 2023051212 2023061614 2023091914 2023111512 2024020712 2022102412 2023012312 2023041212 2023051713 2023062614 2023092112 2023112212 2024021215 2024030612 2024031112 2024042412 2024042514 2024073114 2024080116 2024080913 2024082014; 5400-010-008ITL UDI-DI: 07613327359503, Lot Numbers: 2022092712 2022112912 2023020613 2023042612 2023090412 2023112814 2024021414 2024032612 2022092912 2022113012 2023020712 2023050512 2023090612 2023112914 2024021512 2024040215 2022093014 2022120112 2023020812 2023051012 2023090714 2023113014 2024021612 2024040414 2022100432 2022120212 2023020913 2023051512 2023091312 2023120114 2024021912 2024041614 2022101212 2022120532 2023022112 2023051616 2023091414 2024010914 2024022112 2024041712 2022102114 2022120533 2023030614 2023052312 2023092214 2024011012 2024022212 2024051312 2022102612 2022120632 2023030712 2023052414 2023092732 2024011214 2024022312 2024051412 2022102714 2022120512 2023030812 2023052516 2023100314 2024011512 2024022714 2024052914 2022103132 2022120733 2023030912 2023060114 2023100414 2024011612 2024022712 2024052912 2022110712 2022120732 2023031012 2023060116 2023100932 2024011712 202402281

UPC codes

07613154340804, 07613327359503

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.