Procedure packs: — Class II medical device recall Z-0089-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2023-10-18, distributed nationwide. Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
| Recall number | Z-0089-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-08-16 |
| Classified | 2023-10-10 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13,351 packages |
| UPC / GTIN / UDI-DI | 10195594075507, 10195594271480, 10195594368593, 10195594433482, 10195594447519, 10195594455033, 10195594512552, 10195594560942, 10195594660895, 10195594678562, 10195594733018, 10195594736026, 10195594742065, 10195594764562, 10195594792558, 10195594875060, 10195594878627, 10195594880538, 10195594886516, 10195594891879, 10195594948528, 10195594963200, 10197106002537, 10197106016787, 10197106029800 and 22 more |
| Lot numbers | 16589, 16886, 17214, 17548, 17765, 18167, 24957, 34812, 48287, 900047, 917621, 917630, 917897, 918521, 918902, 919347, 919989, 920364, 920368, 922223, 922662, 923218, 923360, 923782, 923838, 929330, 929434, 930583, 931449, 931699, 931972, 932527, 936774, 940134, 941910, 950758, 964384, 977629, 986478, 986877 and 8 more |
| Model numbers | AN73PPTAC, NE11LMENX, NE11SPDML, NE12ACGTY, NE12LM33J, NE12LM348, NE12LM349, NE12NS388, NE12SPHMS, NE23SPGTH, NE33NROUE, NE33SPO11, NE35NABLD, NE40SPPCH, NE41NBCS9, NE41NBCSE, NE43LNOG6, NE51NBMRL, NE53NEFCH, NE53SFVMF, NE57NP00A, NE57SPKPX, NE69SPFRL, NE73NSCTJ, NE73SPKFL and 12 more |
| Expiration dates | 2023-08-01, 2023-09-01, 2023-12-01, 2024-01-01, 2024-02-01, 2024-04-01, 2024-05-01, 2024-06-01, 2024-07-01, 2024-08-01, 2024-09-01, 2024-10-01, 2024-11-01, 2024-12-01, 2025-01-01, 2025-04-01, 2025-05-01, 2025-06-01 |
Product
Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presource PBDS Cat. PN33DBOU3, Kit, Keep Brain Stimulation, Sterile; (6) Presource PBDS Cat. PN40CD806, Kit, Pedi C D, RWJ, Sterile; (7) Presource PBDS Cat. PN73APVDE, Kit, Neuro Spine Module, Sterile; (8) Presource PBDS Cat. PN73APVD7, Kit, Neuro Spine Module, Sterile; (9) Presource PBDS Cat. POHFSPMHC, Kit, Spine, Sterile; (10) Presource Percutaneous Pack, Cat. SAN73PPTAC, Sterile; (11) Presource Laminectomy Pack Con, Cat. SNECGLPCOB, Sterile; (12) Presource Neuro Spine Pack, Cat. SNECGNSEBF, Sterile; (13) Presource Neuro Spine Pack, Cat. SNECGNSEB4, Sterile; (14) Presource ASMMC Spine Pack, Cat. SNECGSPAUH, Sterile; (15) Presource Spine Pack GSAM, Cat. SNECGSPSGG, Sterile; (16) Presource Cervical Spine Pack, Cat. SNEDKCSWDB, Sterile; (17) Presource Lumbar Lami Pack, Cat. SNEDKLLFLF, Sterile; (18) Presource Posterior Spine Pack, Cat. SNEHDNSRVJ, Sterile; (19) Presource Laminectomy Pack, Cat. SNEOCLPLSC, Sterile; (20) Presource Neuro Pack, Cat. SNEOCNPNBC, Sterile; (21) Presource Laminectomy Pack, Cat. SNE11LMENX, Sterile; (22) Presource Spine Pack, Cat. SNE11SPDML, Sterile; (23) Presource Neuro Cervical Pack, Cat. SNE12ACGTY, Sterile; (24) Presource Neuro Lami Pack, Cat. SNE12LM33J, Sterile; (25) Presource Neuro Lami Pack, Cat. SNE12LM348, Sterile; (26) Presource Neuro Lami Pack, Cat. SNE12LM349, Sterile; (27) Presource Complex Spine Pack, Cat. SNE12NS388, Sterile; (28) Presource Spine Pack, Cat. SNE12SPHMS, Sterile; (29) Presource Spine Pack, Cat. SNE23SPGTH, Sterile; (30) Presource CPT Neuro Angio Pack, Cat. SNE33NROUE, Sterile; (31) Presource CPT Spinal UH Pack, Cat. SNE33SPO11, Sterile; (32) Presource Neuro Lam Accessory Pack, Cat. SNE35NABLD, Sterile; (33) Presource Spine Pack, Cat. SNE40SPPCH, Sterile; (34) Presource Neuro Basic Pk, Cat. SNE41NBCSE, Sterile; (35) Presource Neuro Basic Pk, Cat. SNE41NBCS9, Sterile; (36) Presource Laminectomy Pack, Cat. SNE43LNOG6, Sterile; (37) Presource Spine Pack, Cat. SNE51NBMRL, Sterile; (38) Presource Neuro Pack, Cat. SNE53NEFCH, Sterile; (39) Presource Spinal Fusion Pack, Cat. SNE53SFVMF, Sterile; (40) Presource Spine Pack, Cat. SNE57NP00A, Sterile; (41) Presource Pack Spine Surg SMC SYB, Cat. SNE57SPKPX, Sterile; (42) Presource Spine 70039 Pack, Cat. SNE69SPFRL, Sterile; (43) Presource Custom Neuro Spine Pack, Cat. SNE73NSCTJ, Sterile; (44) Presource Spine Pack, Cat. SNE73SPKFL, Sterile; (45) Presource Spine Pack, Cat. SNE73SPTAC, Sterile; (46) Presource Anterior Cervical Fusion Pack, Cat. SNE81ACNMN, Sterile; and (47) Presource Universal Laminectomy Pack, Cat. SNE81ULNMO, Sterile.
Reason for recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0089-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.