FDA Device recall Z-1089-2023
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d.…
- FDA Device
- Class II
- ongoing
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d.… by Medline Industries Northfield, citing sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1089-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-17 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Sterile Procedural Trays, labeled as the following: a. GYN LAPAROTOMY HARPER PACK-LF b. OB GYN LAP PACK-LF c. VAGINAL HYSTERECTOMY PACK d. DELTA PACK e. MAJOR VAGINAL-LF f. GYN LAPAROSCOPY II
Reason
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Identifiers
| code_info | a. GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/GTIN: 101934892055…a. GYN LAPAROTOMY HARPER PACK-LF, Item Number: DYNJ0160684D, Case UDI/GTIN: 40193489205528, Unit UDI/GTIN: 10193489205527, Lot Number: 22JDA531,22IDB178,22IDA705; b. OB GYN LAP PACK-LF, Item Number: DYNJ43413C, Case UDI/GTIN: 40193489901185, Unit UDI/GTIN: 10193489901184, Lot Number: 22JBS296; c. VAGINAL HYSTERECTOMY PACK, Item Number: DYNJ47624B, Case UDI/GTIN: 40193489735360, Unit UDI/GTIN: 10193489735369, Lot Number: 22KBB429,22IBE503; d. DELTA PACK, Item Number: DYNJ59117A, Case UDI/GTIN: 40193489457897, Unit UDI/GTIN: 10193489457896, Lot Number: 22JMC869,22JMC852,22HMD762; e. MAJOR VAGINAL-LF, Item Number: DYNJ901807G, Case UDI/GTIN: 40193489814157, Unit UDI/GTIN: 10193489814156, Lot Number: 22IDC043; f. GYN LAPAROSCOPY II, Item Number: DYNJS2030D, Case UDI/GTIN: 40193489214148, Unit UDI/GTIN: 10193489214147, Lot Number: 22JDA984; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1089-2023%22
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