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U.S. Department of Health and Human Services

Class 2 Device Recall Presource

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 Class 2 Device Recall Presourcesee related information
Date Initiated by FirmAugust 16, 2023
Date PostedOctober 10, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0090-2024
Recall Event ID 92875
Product Classification Cesarean section tray - Product Code OHM
ProductProcedure pack: Presource PBDS Cat. PLMHCSBHF, Hermann Hospital MHHS, Kit, C Section B MHHS, Sterile.
Code Information Lot #81461, Exp. 6/1/2024 and Exp. 9/1/2024, UDI-DI 10195594542795.
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		Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
FDA Determined
Cause 2		Material/Component Contamination
ActionThe 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 Commerce13,351 total packs
DistributionWorldwide 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 CycleTPLC 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.
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