Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Recall
- Recall Number
- Z-0085-2024
- Event Number
- 92875
- Firm
- Cardinal Health 200, LLC
- FEI Number
- 3001236905
- Product Code
- OGR
- Status
- Open, Classified
- Root Cause
- Material/Component Contamination
- Initiated
- August 16, 2023
- Posted
- October 10, 2023
- Address
- 3651 Birchwood Dr, Waukegan, IL, 60085-8337
Description
Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
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.
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.
13,351 total packs