PlainRecalls
FDA Devices Moderate Class II Ongoing

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 C

Reported: October 18, 2023 Initiated: August 16, 2023 #Z-0091-2024

Product Description

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

Reason for Recall

XXX

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
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.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Cardinal Health 200, LLC. Units affected: 13,351 total packs.
Why was this product recalled?
XXX
Which agency issued this recall?
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0091-2024.