FDA Device recall Z-1691-2023
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital
- FDA Device
- Class II
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital by Deroyal Industries, citing the custom procedure packs contain light handle covers that have been recalled by another firm.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1691-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-17 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.
Reason
The custom procedure packs contain light handle covers that have been recalled by another firm.
Identifiers
| code_info | (1) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58…(1) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58700430, exp 9/1/2026, GTIN pack-00749756362818, case-50749756362813; (3) 89-10509.02 - lot 58775010, exp 12/1/2024, GTIN pack-00749756362832, case-50749756362837; (4) 89-10517.04 - lot 58700579, exp 12/1/2024, GTIN pack-00749756363228, case-50749756363223; (5) 89-10526.04 - lot 58388765, exp 11/1/2024, GTIN pack-00749756363242, case-50749756363247; (6) 89-10530.04 - lot 58543121, exp 11/1/2024, GTIN pack-00749756364447, case-50749756364442; (7) 89-10532.04 - lot 58543905, exp 7/1/2024, GTIN pack-00749756363266, case-50749756363261; (8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, GTIN pack-00749756363532, case-50749756363537; (9) 89-10544.03 - lot 58700000, exp 10/1/2024, GTIN pack-00749756366342, case-50749756366347; (10) 89-10545.02 - lot 58565830, exp 3/1/2024, GTIN pack-00749756363556, case-50749756363551; (11) 89-10552.02 - lot 58700667, 58700675, and 5 |
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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-1691-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.