FDA Device recall Z-2917-2020
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - 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 8.0 - 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-2917-2020 |
| 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 8.0 - 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: 2D72NT80X Lot #: TS19060095, TS19060169, TS19060328, TS19060357, TS19070100, TS19080183, TS19080225, TS1908…Item Code: 2D72NT80X Lot #: TS19060095, TS19060169, TS19060328, TS19060357, TS19070100, TS19080183, TS19080225, TS19080308, TS19090043, TS19090188, TS19090292, TS19100150, TS19100214, TS19100282, TS19110050, TS19110115, TS19110295, TS19110334, TS19120049, TS20050165 Additional Affected Lots as of 10/20/20: TS20040334, TS20040358, TS20040359, TS20050106, TS20050322, TS20060026, TS20060084 |
|---|
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-2917-2020%22
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