Cardinal Health 200, LLC: Device Recall

Recall Details

Recall Number

Z-0908-2025

Classification

Class II

Product Type

Device

Recalling Firm

Cardinal Health 200, LLC

Status

Ongoing

Date Initiated

11/08/2024

Location

Waukegan, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

512,786 total units

Reason for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Product Description

Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913; 7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914; 8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951; 9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952; 10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953; 11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954; 12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955; 13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956; 14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957; 15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958; 16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959; 17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A; 18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C; 19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F; 20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G; 21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1; 22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2; 23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB; 24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC; 25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD; 26) DIEP PACK,Catalog Number SBA11DPS10; 27) DIEP PACK,Catalog Number SBA11DPS11; 28) DIEP PACK,Catalog Number SBA11DPS12; 29) DIEP PACK,Catalog Number SBA11DPS13; 30) DIEP PACK,Catalog Number SBA11DPS14; 31) DIEP PACK,Catalog Number SBA11DPS15; 32) DIEP PACK,Catalog Number SBA11DPS16; 33) DIEP PACK,Catalog Number SBA11DPS17; 34) DIEP PACK,Catalog Number SBA11DPS18; 35) DIEP PACK,Catalog Number SBA11DPS19; 36) DIEP PACK,Catalog Number SBA11DPS20; 37) DIEP PACK,Catalog Number SBA11DPS21; 38) DIEP PACK,Catalog Number SBA11DPS22; 39) DIEP PACK,Catalog Number SBA11DPSB4; 40) DIEP PACK,Catalog Number SBA11DPSB5; 41) DIEP PACK,Catalog Number SBA11DPSB6; 42) DIEP PACK,Catalog Number SBA11DPSB7; 43) DIEP PACK,Catalog Number SBA11DPSB8; 44) DIEP PACK,Catalog Number SBA11DPSB9; 45) DIEP PACK,Catalog Number SBA11DPSBD; 46) DIEP PACK,Catalog Number SBA11DPSBE; 47) DIEP PACK,Catalog Number SBA11DPSBF; 48) DIEP PACK,Catalog Number SBA11DPSBG; 49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1; 50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2; 51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3; 52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4; 53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5; 54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6; 55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB; 56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC; 57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD; 58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE; 59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10; 60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11; 61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12; 62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13; 63) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Other Recalls by Cardinal Health 200, LLC

• Class II: Risk 12/26/2025
  The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
• Class II: Risk 11/12/2025
  Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
• Class II: Risk 09/18/2025
  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
• Class II: Risk 09/18/2025
  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
• Class II: Risk 09/18/2025
  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

View all recalls by Cardinal Health 200, LLC →