PlainRecalls
FDA Devices Moderate Class II Ongoing

Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.

Reported: October 18, 2023 Initiated: August 16, 2023 #Z-0083-2024

Product Description

Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.

Reason for Recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
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.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.. Recalled by Cardinal Health 200, LLC. Units affected: 13,351 total packs.
Why was this product recalled?
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Which agency issued this recall?
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0083-2024.