Reported Jun 14, 2023 · Ongoing
Sterile custom surgical procedure packs
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
Sterile custom surgical procedure packs
26 of 26 products
| # | Product as published |
|---|---|
| 1 | (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital |
| 2 | (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital |
| 3 | (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital |
| 4 | (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center |
| 5 | (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center |
| 6 | (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center |
| 7 | (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center |
| 8 | (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp |
| 9 | (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp |
| 10 | (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital |
| 11 | (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital |
| 12 | (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital |
| 13 | (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital |
| 14 | (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital |
| 15 | (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital |
| 16 | (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital |
| 17 | (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital |
| 18 | (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital |
| 19 | (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital |
| 20 | (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital |
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Barcodes Product as published pack-007497563627880074975636278850749756362783(1) 89-10507.02 - lot 58700464, exp 12/1/2024, , case-50749756362783 pack-007497563628180074975636281850749756362813(2) 89-10508.02 - lot 58700430, exp 9/1/2026, , case-50749756362813 pack-007497563628320074975636283250749756362837(3) 89-10509.02 - lot 58775010, exp 12/1/2024, , case-50749756362837 pack-007497563632280074975636322850749756363223(4) 89-10517.04 - lot 58700579, exp 12/1/2024, , case-50749756363223 pack-007497563632420074975636324250749756363247(5) 89-10526.04 - lot 58388765, exp 11/1/2024, , case-50749756363247 pack-007497563644470074975636444750749756364442(6) 89-10530.04 - lot 58543121, exp 11/1/2024, , case-50749756364442 pack-007497563632660074975636326650749756363261(7) 89-10532.04 - lot 58543905, exp 7/1/2024, , case-50749756363261 pack-007497563635320074975636353250749756363537(8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, , case-50749756363537 pack-007497563663420074975636634250749756366347(9) 89-10544.03 - lot 58700000, exp 10/1/2024, , case-50749756366347 pack-007497563635560074975636355650749756363551(10) 89-10545.02 - lot 58565830, exp 3/1/2024, , case-50749756363551 pack-007497563635490074975636354950749756363544(11) 89-10552.02 - lot 58700667, 58700675, and 58724108, exp 12/1/2024, , case-50749756363544 pack-007497563636240074975636362450749756363629(12) 89-10553.02 - lot 58544060, exp 11/1/2024, , case-50749756363629 pack-007497563634400074975636344050749756363445(13) 89-10554.02 - lot 58544166, exp 12/1/2024, , case-50749756363445 pack-007497563636480074975636364850749756363643(14) 89-10555.02 - lot 58589647 and 58724116, exp 12/1/2024, , case-50749756363643 pack-007497563642870074975636428750749756364282(15) 89-10556.02 - lot 58589567, exp 12/1/2024, , case-50749756364282 pack-007497563644300074975636443050749756364435(16) 89-10558.04 - lot 58542769, exp 11/1/2024, lot 58621694 and 58699993, exp 12/1/2024, , case-50749756364435 pack-007497563637780074975636377850749756363773(17) 89-10560.03 - lot 58543201, 58554436, and 58700499, exp 9/1/2024, , case-50749756363773 pack-007497563637230074975636372350749756363728(18) 89-10561.02 - lot 58542793, exp 11/1/2024, lot 58589591 and 58738016, exp 12/1/2024, , case-50749756363728 pack-007497563641400074975636414050749756364145(19) 89-10562.02 - lot 58621820, exp 10/1/2024, , case-50749756364145 pack-007497563637610074975636376150749756363766(20) 89-10564.02 - lot 58543083, exp 11/1/2024, and lot 58700501, exp 12/1/2024, , case-50749756363766 - Amount recalled
- 1,391 cases (2,972 packs)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- VA
Why it was recalled
The custom procedure packs contain light handle covers that have been recalled by another firm.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new DeRoyal Industries Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.