FDA Device recall Z-2912-2020
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or…
- FDA Device
- Class II
- completed
- Published 2020-09-09
On 2020-09-09 the FDA classified a Class II recall of PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or… by Cardinal Health 200, citing A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2912-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-07-29 |
| Published | 2020-09-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
Reason
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Identifiers
| code_info | Item Code: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS2001…Item Code: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092 Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2912-2020%22
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