Class 2 Device Recall Presource

• Date Initiated by Firm: August 16, 2023
• Date Posted: October 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0091-2024
• Recall Event ID: 92875
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Procedure packs: (1) Presource PBDS Cat. PN33BPCR2, Kit, Back, Sterile; (2) Presource PBDS Cat. POCGANA11, Kit, ARN Anterior Hip, Sterile; (3) Presource PBDS Cat. PODKHAKAB, Kit, Hip Arthroscopy, Sterile; (4) Presource PBDS, Cat. POMHKAESV, Kit, Knee Arthroscopy, SE, Sterile; (5) Presource PBDS Cat. POMHLEE11, Kit, Extremity, SE, Sterile; (6) Presource PBDS Cat. POMVTHANLE, Kit, Anterior Hip, Sterile; (7) Presource PBDS Cat. POVMPAB11, Kit, PAO Pack, Barnes Jewish, Sterile; (8) Presource PBDS Cat. PO08LXG21, Kit, Extremity, Grant, Sterile; (9) Presource PBDS Cat. PO11HRFH6, Kit, Anterior Hip, Sterile; (10) Presource PBDS Cat. PO11OTASS8, Kit, Trauma Hip A and B, Sterile; (11) Presource PBDS Cat. PO11OTSSP, Kit, Trauma Knee A and B, Sterile; (12) Presource PBDS Cat. PO11THAS13, Kit, Anterior Hip, Sterile; (13) Presource PBDS Cat. PO12AHSUQ, Kit, Anterior Hip, Sterile; (14) Presource PBDS Cat. PO12AHSU7, Kit, Anterior Hip, Sterile; (15) Presource PBDS, Cat. PO18AHEFG, Kit, Anterior Hip, Sterile; (16) Presource PBDS Cat. PO3LHPLM2, Kit, Hip Pinning, Sterile; (17) Presource PBDS Cat. PO3LHPLM3, Kit, Hip Pinning, Sterile; (18) Presource PBDS Cat. PO33AHCRA, Kit, Anterior Hip, Sterile; (19) Presource PBDS Cat. PO56MLGRA, Kit, MC Lower Extremity, Sterile; (20) Presource Spine Pack, Cat. SNECGSPAHB,Sterile; (21) Presource Spine Pack, Cat. SNECGSPAH4, Sterile; (22) Presource Ortho Laminectomy Pack, Cat. SNE12OL89A, Sterile; (23) Presource ACD Pack, Cat. SNE33ACCRD, Sterile; (24) Presource Anterior Fusion Pack, Cat. SNE33AFC18, Sterile; (25) Presource Lumbar Disk Pack, Cat. SNE33LMCAB, Sterile; (26) Presource SDMC Ortho Spine Accessory Pk, Cat. SNE73SAKSD, Sterile; (27) Presource Hip Arthroscopy Pack, Cat. SOPCNHAMSD, Sterile; (28) Presource Anterior Approach Total Hip Pk, Cat. SOPDKAHC12, Sterile; (29) Presource Physician Partner of America, Cat. SOPHFLSHAC, Sterile; (30) Presource MH Hip With Curtain Std Pack, Cat. SOPMHHCM10, Sterile; (31) Presource Back Pack, Cat. SOPOCBPLSD, Sterile; (32) Presource HFHS Ortho Spine Pack, Cat. SOPW1OSHFM, Sterile; (33) Presource PED Extremity Pack, Cat. SOP11PER12, Sterile; (34) Presource Hip Arthroscopy Pack, Cat. SOP12HAGTC, Sterile; (35) Presource OPSC Hip Arthroscopy Pack, Cat. SOP12HAUVE, Sterile; (36) Presource Major Ortho, Cat. SOP12MJHM6, Sterile; (37) Presource Pedi Ortho Spine W Basin Pack, Cat. SOP22PSMRE, Sterile; (38) Presource Lower Extremity Pack 302095, Cat. SOP3LLESGK, Sterile; (39) Presource ORIF Wrist Sturgeon Pack, Cat. SOP30ACSCG, Sterile; (40) Presource Ensemble Pied Cheville 3, Cat. SOP30AKJTF, Sterile; (41) Presource Fracture Pack, Cat. SOP30FRUHE, Sterile; (42) Presource Anterior Total Hip Pack, Cat. SOP30HALHB, Sterile; (43) Presource Hip Pack, Cat. SOP30HPWME, Sterile; (44) Presource Hip Scope Pack, Cat. SOP30HSCHE, Sterile; (45) Presource Ortho Split Pack, Cat. SOP30OSVI8, Sterile; (46) Presource Pack Trauma Uppr Extrmty Civic, Cat. SOP30UPOHD, Sterile; (47) Presource Anterior Hip Pack, Cat. SOP32AHGMH, Sterile; (48) Presource Anterior Tha Pack, Cat. SOP33ANOOI, Sterile; (49), Presource CPT Ortho Custom UH Pack, Cat. SOP33OROUJ, Sterile; (50) Presource CPT Ortho Custom UH Pack, Cat. SOP33OROU5, Sterile; (51) Presource Anterior Hip Pk, Cat. SOP35AHAMG, Sterile; (52) Presource Hip Pack, Cat. SOP41HISP6, Sterile; (53) Presource Spine Tray, Cat. SOP44STHPC, Sterile; (54) Presource Anterior Hip Pack, Cat. SOP5BAHHEE, Sterile; (55) Presource Essentia Anterior Hip Surgi Pk, Cat. SOP5BHSEHD, Sterile; (56) Presource CPT Ortho Custom James Pk, Cat. SOP5CCJOUH, Sterile; (57) Presource Back Part 1, Cat. SOP51BAKOF, Sterile; (58) Presource Back Part 1, Cat. SOP51BAKO9, Sterile; (59) Presource Pack Total Hip Anter Surg WMC, Cat. SOP53APKP4, Sterile; (60) Presource West Hip Anterior Total Pack, Cat. SOP56HAMT8, Sterile; (61) Presource Anterior Hip Pack, Cat. SOP57AHSH5, Sterile; (62) Presource Total Hip Pack, Cat. SOP6VTHPOA, Sterile; (63) Presource ASU Hip Arthroscopy Pack, Cat. S
• Code Information: (1) Cat. PN33BPCR2 - Lot #986971, Exp. 9/1/2024, UDI-DI 10197106132319; (2) Cat. POCGANA11 - Lot #936749, Exp. 8/1/2024, UDI-DI 10197106027257; (3) Cat. PODKHAKAB - Lot #18022, Exp. 5/1/2024, UDI-DI 10888439441819; (4) Cat. POMHKAESV - Lot #967651, Exp. 12/1/2023, UDI-DI 10195594543341; (5) Cat. POMHLEE11 - Lot #39223, Exp. 8/1/2024, UDI-DI 10197106255087; (6) Cat. POMVTHANLE - Lot #926669, Exp. 9/1/2023, UDI-DI 10195594471781; (7) Cat. POVMPAB11 - Lot #951430, Exp. 8/1/2024, UDI-DI 50197106054701; (8) Cat. PO08LXG21 - Lot #941775, Exp. 12/1/2024, UDI-DI 10197106032404; (9) Cat. PO11HRFH6 - Lot #921333, Exp. 5/1/2024, UDI-DI 10195594894191; (10) Cat. PO11OTASS8 - Lot #920211, Exp. 2/1/2024, UDI-DI 10195594888121; (11) Cat. PO11OTSSP - Lot #57290, Exp. 4/1/2024, UDI-DI 10197106108611; (12) Cat. PO11THAS13 - Lot #966763, Exp. 8/1/2024, UDI-DI 10197106087190; (13) Cat. PO12AHSUQ - Lot #930429, Exp. 1/1/2024, UDI-DI 10195594397760; (14) Cat. PO12AHSU7 - Lot #17680, Exp. 10/1/2024, UDI-DI 10197106201329; (15) Cat. PO18AHEFG - Lot #940003, Exp. 8/1/2024, UDI-DI 10888439910193; (16) Cat. PO3LHPLM2 - Lot #905668, Exp. 6/1/2025, UDI-DI 10195594828790; (17) Cat. PO3LHPLM3 - Lot #925611, Exp. 7/1/2025, UDI-DI 10197106000298; (18) Cat. PO33AHCRA - Lot #998611, Exp. 1/1/2025, UDI-DI 10195594899264; (19) Cat. PO56MLGRA - Lot #4327, Exp. 7/1/2025, UDI-DI 10197106115008; (20) Cat. SNECGSPAHB - Lot #986454, Exp. 9/1/2024, UDI-DI 10195594020798; (21) Cat. SNECGSPAH4 - Lot #40840, Exp. 9/1/2024, UDI-DI 10197106266328; (22) Cat. SNE12OL89A - Lot #18306, Exp. 12/1/2023 and 5/1/2024, UDI-DI 10195594527723; (23) Cat. SNE33ACCRD - Lot #931311, Exp. 6/1/2024, UDI-DI 10195594895839; (24) Cat. SNE33AFC18 - Lot #941894, Exp. 8/1/2024, UDI-DI 10197106033807; (25) Cat. SNE33LMCAB - Lot #922696, Exp. 8/1/2024 and Exp. 5/1/2024, UDI-DI 10195594472559; (26) Cat. SNE73SAKSD - Lot #920769, Exp. 8/1/2024, UDI-DI 10888439615173; (27) Cat. SOPCNHAMSD - Lot #969039, Exp. 9/1/2024 and Exp. 7/1/2024, UDI-DI 10888439903140; (28) Cat. SOPDKAHC12 - Lot #997357, Exp. 9/1/2024, UDI-DI 10197106163337; (29) Cat. SOPHFLSHAC - Lot #998464, Exp. 4/1/2027, UDI-DI 10888439912098; (30) Cat. SOPMHHCM10 - Lot #996397, Exp. 12/1/20025, UDI-DI 10197106163634; (31) Cat. SOPOCBPLSD - Lot #893040, Exp. 4/1/2024, UDI-DI 10888439909210; (32) Cat. SOPW1OSHFM - Lot #931594, Exp. 7/1/2024, UDI-DI 10888439936759; (33) Cat. SOP11PER12 - Lot #920426, Exp. 8/1/2023, UDI-DI 10195594880781; (34) Cat. SOP12HAGTC - Lot #986429, Exp. 1/1/2024, UDI-DI 10195594961923; (35) Cat. SOP12HAUVE - Lot #64393, Exp. 11/1/2024, UDI-DI 10197106300657; (36) Cat. SOP12MJHM6 - Lot #922502, Exp. 12/1/2023, UDI-DI 10195594892081; (37) Cat. SOP22PSMRE - Lot #928986, Exp. 6/1/2024, UDI-DI 10888439917376; (38) Cat. SOP3LLESGK - Lot #959551, Exp. 4/1/2025 and Exp. 5/1/2025, UDI-DI 10195594495930; (39) Cat. SOP30ACSCG - Lot #929766, Exp. 3/1/2027, UDI-DI 10195594759780; (40) Cat. SOP30AKJTF - Lot #16244, Exp. 11/1/2027, UDI-DI 10197106080160; (41) Cat. SOP30FRUHE - Lot #986684, Exp. 12/1/2024, UDI-DI 10195594614263; (42) Cat. SOP30HALHB - Lot #924124, Exp. 12/1/2025, UDI-DI 10195594737351; (43) Cat. SOP30HPWME - Lot #991876, Exp. 6/1/2024, UDI-DI 10888439936414; (44) Cat. SOP30HSCHE - Lot #12487, Exp. 12/1/2024, UDI-DI 10888439853025; (45) Cat. SOP30OSVI8 - Lot #921913, Exp. 6/1/2027, UDI-DI 10195594891343; (46) Cat. SOP30UPOHD - Lot #929776, Exp. 10/1/2026, UDI-DI 10195594469139; (47) Cat. SOP32AHGMH - Lot #71002, Exp. 1/1/2027, UDI-DI 10197106088661; (48) Cat. SOP33ANOOI - Lot #998668, Exp. 4/1/2024, UDI-DI 10197106026588; (49) Cat. SOP33OROUJ - Lot #930189, Exp. 6/1/2024 and Exp. 5/1/2024, UDI-DI 10195594700683; (50) Cat. SOP33OROU5 - Lot #918471, Exp. 2/1/2024, UDI-DI 10195594876340; (51) Cat. SOP35AHAMG - Lot #923516, Exp. 4/1/2024, UDI-DI 10195594571696, (52) Cat. SOP41HISP6 - Lot #916958, Exp. 2/1/2024, UDI-DI 10195594873691; (53) Cat. SOP44STHPC - Lot #12393, Exp. 12/1/2024, UDI-DI 10888439912180; (54) Cat. SOP5BAHHEE - Lot #53599, Exp. 12/1/2024, UDI-DI 10195594532246; (55) Cat. SOP5BHSEHD - Lot #986063, Exp. 10/1/2024, UDI-DI 10888439654790; (56) Cat. SOP5CCJOUH - Lot #920091, Exp. 7/1/2024, UDI-DI 10195594663902; (57) Cat. SOP51BAKOF - Lot #966211, Exp. 10/1/2024, UDI-DI 10887488579931; (58) Cat. SOP51BAKO9 - Lot #927573, Exp. 6/1/2024, UDI-DI 10197106005507; (59) Cat. SOP53APKP4 - Lot #929995, Exp. 2/1/2024, UDI-DI 10197106012741; (60) Cat. SOP56HAMT8 - Lot #920050, Exp. 10/1/2023, UDI-DI 10195594882600; (61) Cat. SOP57AHSH5 - Lot #986901, Exp. 12/1/2024, UDI-DI 10197106133361; (62) Cat. SOP6VTHPOA - Lot #986320, Exp. 10/1/2024, UDI-DI 10195594408312; (63) Cat. SOP69AHKCF - Lot #915225, Exp. 3/1/2024, UDI-DI 10887488576046; (64) Cat. SOP69AHKC2 - Lot #912556, Exp. 3/1/2024, UDI-DI 10195594862879; (65) Cat. SOP69AHMRI - Lot #4205, Exp. 8/1/2024, Exp. 12/1/2024, and Exp. 6/1/2024, UDI-DI 10195594097295; (66) Cat. SOP69SHWMR - Lot #913072, Exp. 3/1/2024, UDI-DI 10195594106331; (67) Cat. SOP69TAKT3 - Lot #922930, Exp. 6/1/2024, UDI-DI 10195594892852; (68) Cat. SOP69TAKT6 - Lot #986238, Exp. 10/1/2024, UDI-DI 10197106133132; (69) Cat. SOP69TSKBA - Lot #986066, Exp. 1/1/2024, UDI-DI 10195594464431; (70) Cat. SOP73HAKPH - Lot #942491, Exp. 7/1/2024, UDI-DI 10195594446345; (71) Cat. SOP73SPDOC - Lot #970296, Exp. 2/1/2024, UDI-DI 10888439930733; and (72) Cat. SOP82AHBFK - Lot #18539, Exp. 7/1/2023 and Exp. 12/1/2023, UDI-DI 10888439974881.
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: 800-292-9332
• Manufacturer Reason for Recall: XXX
• FDA Determined Cause: Material/Component Contamination
• Action: The recalling firm issued letters dated 8/17/2023 via overnight mail on 8/16/2023. The letter explained the reason for recall, risk to health, and the actions required and included a copy of the supplier's letter. The actions were for the consignee to (1) review their inventory for the affected catalog and lot numbers in the enclosed attachment; (2) segregate and quarantine the affected product and follow instructions in the letter for product return; (3)notify any customers to whom they may have distributed/forwarded the affected product and share a copy of the recall letter to notify them; and (4) return the enclosed acknowledgment form via FAX or email as to whether they have the affected product. Instructions for contacting the appropriate Customer Service groups are provided to arrange for return and credit/replacement of the affected product. An example of a label is provided to show where to find the catalog number, lot number, and expiration date.
• Quantity in Commerce: 13,351 total packs
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.