CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report
Procedure packs: Presource Pbds Cat., Kit, Neuro Imas, Sterile recalled
Cardinal Health 200 is recalling Procedure packs: Presource Pbds Cat., Kit, Neuro Imas, Sterile, distributed nationwide in the US. The recall was initiated on 16 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0089-2024
- FDA event ID
- 92875
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Aug 2023
- FDA classified
- 10 Oct 2023
- Reported
- 18 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 16 Aug 2023 | Recall initiated by company | |
| 10 Oct 2023 | Classified by FDA | +55 days |
| 18 Oct 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Nationwide ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Why was it recalled?
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Which lots are affected?
(1) Cat. PNVMNIB21 - Lot #920364, Exp. 6/1/2024, UDI-DI 10195594891879; (2) Cat. PN08LAG13 - Lot #920368, Exp. 6/1/2024, UDI-DI 10195594886516; (3) Cat. PN08LAG17 - Lot #987136, Exp. 11/1/2024, UDI-DI 10197106132944; (4) Cat. PN11SFS40 - Lot #917897, Exp. 6/1/2024, UDI-DI 10195594875060; (5) Cat. PN33DBOU3 - Lot #918902, Exp. 8/1/2023, UDI-DI 10195594878627; (6) Cat. PN40CD806 - Lot #17765, Exp. 5/1/2024, UDI-DI 10197106202968; (7) Cat. PN73APVDE - Lot #936774, Exp. 9/1/2023, UDI-DI 10195594742065; (8) Cat. PN73APVD7 - Lot #931972, Exp. 9/1/2023, UDI-DI 10197106016787; (9) Cat. POHFSPMHC - Lot #929330, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903096; (10) Cat. SAN73PPTAC - Lot #964384, Exp. 6/1/2025, UDI-DI 10888439008166; (11) Cat. SNECGLPCOB - Lot #917630, Exp. 6/1/2024, UDI-DI 10195594560942; (12) Cat. SNECGNSEBF - Lot #940134, Exp. 8/1/2024, UDI-DI 10197106002537; (13) Cat. SNECGNSEB4 - Lot #990736, Exp. 11/1/2024, UDI-DI 10197106143315; (14) Cat. SNECGSPAUH - Lot #923838, Exp. 4/1/2024, UDI-DI 10195594271480; (15) Cat. SNECGSPSGG - Lot #17548, Exp. 11/1/2024 and Exp. 5/1/2024, UDI-DI 10197106131572; (16) Cat. SNEDKCSWDB - Lot #977629, Exp. 10/1/2024, UDI-DI 10197106029800; (17) Cat. SNEDKLLFLF - Lot #917621, Exp. 5/1/2024 and Exp. 11/1/2024, UDI-DI 10195594948528; (18) Cat. SNEHDNSRVJ - Lot #18167, Exp. 5/1/2024, UDI-DI 10888439902938; (19) Cat. SNEOCLPLSC - Lot #16886, Exp. 5/1/2025, UDI-DI 10195594963200; (20) Cat. SNEOCNPNBC - Lot #922662, Exp. 1/1/2024, UDI-DI 10887488974897; (21) Cat. SNE11LMENX - Lot #918521, Exp. 6/1/2024, UDI-DI 10195594736026; (22) Cat. SNE11SPDML - Lot #923218, Exp. 9/1/2023, UDI-DI 10195594433482; (23) Cat. SNE12ACGTY - Lot #16589, Exp. 6/1/2024, UDI-DI 10888439665093; (24) Cat. SNE12LM33J - Lot #923782, Exp. 4/1/2024, UDI-DI 10888439665116; (25) Cat. SNE12LM348 - Lot #992523, Exp. 7/1/2024, UDI-DI 10197106150399; (26) Cat. SNE12LM349 - Lot #997471, Exp. 12/1/2024, UDI-DI 10197106162149; (27) Cat. SNE12NS388 - Lot #987470, Exp. 12/1/2024, UDI-DI 10197106134146; (28) Cat. SNE12SPHMS - Lot #923360, Exp. 7/1/2024, UDI-DI 10195594660895; (29) Cat. SNE23SPGTH - Lot #999249, Exp. 1/1/2025, UDI-DI 10197106078150; (30) Cat. SNE33NROUE - Lot #919347, Exp. 12/1/2024, UDI-DI 10195594792558; (31) Cat. SNE33SPO11 - Lot #941910, Exp. 9/1/2024, UDI-DI 10197106034149; (32) Cat. SNE35NABLD - Lot #922223, Exp. 6/1/2025, UDI-DI 10888439939651; (33) Cat. SNE40SPPCH - Lot #48287, Exp. 12/1/2023 and Exp. 7/1/2024, UDI-DI 10195594455033; (34) Cat. SNE41NBCSE - Lot #990152, Exp. 10/1/2024, UDI-DI 10888439916355; (35) Cat. SNE41NBCS9 - Lot #919989, Exp. 7/1/2024, UDI-DI 10195594880538; (36) Cat. SNE43LNOG6 - Lot #34812, Exp. 5/1/2024, UDI-DI 10197106250495; (37) Cat. SNE51NBMRL - Lot #932527, Exp. 8/1/2024, UDI-DI 10888439575125; (38) Cat. SNE53NEFCH - Lot #24957, Exp. 5/1/2024 and Exp. 8/1/2024, UDI-DI 10195594368593; (39) Cat. SNE53SFVMF - Lot #986877, Exp. 2/1/2024, UDI-DI 10195594764562; (40) Cat. SNE57NP00A - Lot #930583, Exp. 7/1/2024, UDI-DI 10195594512552; (41) Cat. SNE57SPKPX - Lot #929434, Exp. 10/1/2024 and Exp. 7/1/2024, UDI-DI 10195594075507; (42) Cat. SNE69SPFRL - Lot #931449 Exp. 7/1/2024, UDI-DI 10195594447519; (43) Cat. SNE73NSCTJ - Lot #986478, Exp. 11/1/2024, UDI-DI 10195594678562; (44) Cat. SNE73SPKFL - Lot #950758, Exp. 8/1/2024, UDI-DI 10888439662986; (45) Cat. SNE73SPTAC - Lot #900047, Exp. 5/1/2024 and Exp. 6/1/2024, UDI-DI 10888439136975; (46) Cat. SNE81ACNMN - Lot #17214, Exp. 4/1/2025, and Lot #D221752, Exp. 5/1/2024, UDI-DI 10195594733018; and (47) Cat. SNE81ULNMO - Lot #931699, Exp. 5/1/2024, UDI-DI 10888439934113.
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
9 other products · FDA event 92875This product is part of a recall event; the main page for the event is Procedure pack: Presource PBDS Cat recalled by Cardinal Health 200.
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |