Recalls / —

—#202933

Product

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

FDA product code

OGR — Ear, Nose, And Throat Surgical Tray

Device class

Class 1

Medical specialty

Ear, Nose, Throat

Affected lot / code info

Lot #967679, Exp. 9/1/2024, UDI-DI 10195594543259.

Why it was recalled

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

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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.

Recalling firm

Firm

Cardinal Health 200, LLC

Address

3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2023-08-16

Posted by FDA

2023-10-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.