FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
- Recall number
- Z-0083-2024
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
- Status
- Open, Classified
- Initiated
- 2023-08-16
- Posted
- 2023-10-10
- Terminated
- not on file
- Reason
- Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
- Root cause
- Material/Component Contamination
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- (1) Cat. SBAHFPTAS2 - Lot #900813, exp. 1/1/2025, UDI-DI 10195594810351; and (2) Cat. SNE37ANMOF - Lot #32724, exp. 4/1/2025, UDI-DI 10195594576080.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFQ
- Firm FEI
- 3001236905
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28