FDA Device recall Z-1775-2016
American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges by American Surgical, citing product packaging defective compromising sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1775-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | American Surgical |
| Distribution | US |
Product
American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Reason
Product packaging defective compromising sterility
Identifiers
| code_info | Lot numbers: 2015/08 CF 2015/09 CI 2015/10 CM 2015/11 AH 2015/10 CA 2015/11 AM 2015/11 BO 2015/12 AL 2015/11…Lot numbers: 2015/08 CF 2015/09 CI 2015/10 CM 2015/11 AH 2015/10 CA 2015/11 AM 2015/11 BO 2015/12 AL 2015/11 BS 2015/11 BV 2015/11 BY 2015/12 AT 2015/12 BF 2015/12 CA |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2016%22
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