FDA Device recall Z-1235-2020
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-1235-2020 |
| 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. Additional kits produced through February 19, 2020 were included.
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: CHIP99CP6C 241107; CHIP99CP6C 255309; CHIP99CP6C 299932; CHIP99CP8A 181346; CHIP99CP8A 28…Catalog Number and Lot Code: CHIP99CP6C 241107; CHIP99CP6C 255309; CHIP99CP6C 299932; CHIP99CP8A 181346; CHIP99CP8A 282695; CHIP99CP8A 282696; CHIP99CP8A 282697; CHIP99HA1B 165018; CHIP99HA1B 248383; CHIP99HA1B 305740; CHIP99HA1B 330666; CHIP99HA1B 330666; CHIP99HA1B 363766; CHIP99LC1F 118473; CHIP99LC1F 279185; CHIP99LC1F 298252; CHIP99LC1F 309240; CHIP99LC1F 340201; CHIP99LC1F 340315; CHIP99LC1F 367435; CHIP99LC2E 248115; CHIP99LC2E 306502; CHIP99LC2E 321583; CHIP99LC2E 358454; CHIP99LC3D 147129; CHIP99LC3D 294307; CHIP99LC3D 334112; CHIP99MJ1E 987331; CHIP99MJ1E 988306; CHIP99MJ1E 123963; CHIP99MJ1E 127110; CHIP99MJ1E 152812; CHIP99MJ1E 154622; CHIP99MJ1E 174616; CHIP99MJ1E 201151; CHIP99MJ1E 230122; CHIP99MJ1E 255908; CHIP99MJ1E 282115; CHIP99MJ1E 282116; CHIP99MJ1E 282116; CHIP99MJ1E 282117; CHIP99MJ1E 308190; CHIP99MJ1E 308190; CHIP99MJ1E 311734; CHIP99MJ1E 321582; CHIP99MJ1E 327149; CHIP99MJ1E 368850; CHIP99MJ27 986631; CHIP99MJ28 988301; CHIP99MJ2F 993366; CHIP99MJ2F 110964; C |
|---|
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-1235-2020%22
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