FDA Device recall Z-1301-2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 1…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 1… by Cardinal Health 200, citing the kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1301-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-31 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Reason
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Identifiers
| code_info | Catalog Number and Lot Code: PB08GAGHS 521235; PB08GAGHS 529320; PB08GAGHS 554815; PB08GAGHS 557236; PB08GAGHS 560162;…Catalog Number and Lot Code: PB08GAGHS 521235; PB08GAGHS 529320; PB08GAGHS 554815; PB08GAGHS 557236; PB08GAGHS 560162; PB08GAGHS 562676; PB08GIGHR 552864; PB08GIGHR 559707; PB08GIGHR 561420; PB08HSGH5 517846; PB08HSGHK 504968; PB08HSGHK 544674; PB08HSGHK 554810; PB08HSGHK 558443; PB08HSGHK 562679; PB08IVGH3 519354; PB08IVGHO 503340; PB08IVGHO 509979; PB08IVGHO 551950; PB08IVGHO 554195; PB08IVGHO 556756; PB08IVGHO 559958; PB08IVGHO 562283; PB08LSGH3 517883; PB08LSGHE 513408; PB08LSGHE 550220; PB08LSGHE 556248; PB08LSGHE 561562; PB08MVGHQ 521902; PB08MVGHQ 523275; PB08MVGHQ 528216; PB08MVGHQ 549498; PB08MVGHQ 556443; PB08MVGHQ 559599; PB08MVGHQ 562466; PB11DCXXA 344716; PB11DCXXA 372505; PB11FSCHN 541668; PB13LSFHG 195957; PB13LSFHG 316506; PB13LSFHG 350830; PB13LSFHH 373873; PB13UGNT7 303901; PB13UGNTJ 118704; PB13UGNTJ 143922; PB13UGNTK 255172; PB13UGNTK 327799; PB13UGNTK 360114; PB15LHFCJ 248323; PB15LHFCJ 312264; PB15LHFCJ 342369; PB15LHFCJ 366746; PB1DAHUNI 180662; PB1DAHUNJ 333601 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1301-2020%22
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