Cardinal Health 200, LLC: Medical Device Recall in 2023 - (Recall #: Z-0089-2024)

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.

Class II

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

(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.

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.

Voluntary: Firm initiated