FDA Device recall Z-2915-2020
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - 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 7.0 - 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-2915-2020 |
| 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 7.0 - 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: 2D72NT70X Lot #: TS19060339, TS19070029, TS19070108, TS19070180, TS19070285, TS19080035, TS19080064, TS1908…Item Code: 2D72NT70X Lot #: TS19060339, TS19070029, TS19070108, TS19070180, TS19070285, TS19080035, TS19080064, TS19080140, TS19080186, TS19080271, TS19090054, TS19090149, TS19090266, TS19100058, TS19100107, TS19100186, TS19100308, TS19110038, TS19110090, TS19110157, TS19110225, TS19120005, TS20030299, TS20040046 Additional Affected Lots as of 10/20/20: TS20040204, TS20040260, TS20040312, TS20050113, TS20050157, TS20050289, TS20050290, TS20050391, TS20060093, TS20060152, TS20060153, TS20060204, TS20060237, TS20060238, TS20060296, TS20060304, TS20060305, TS20070020, TS20070107 |
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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: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2915-2020%22
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