Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
This recall is currently active, issued October 10, 2023. It was issued by Cardinal Health 200, Llc.
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- August 16, 2023
- Posted
- October 10, 2023
- Recall Number
- Z-0085-2024
- Quantity
- 13,351 total packs
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
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.
Lot / Code Info
Lot #967679, Exp. 9/1/2024, UDI-DI 10195594543259.
Root Cause
Material/Component Contamination
Action Taken
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.