Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan,

FDA device recall Z-2757-2017 · posted 2017-07-07 · Terminated

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

Action taken

Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken: 1. Inspect your inventory for the affected product code and lot number (listed on the package) 2. segregate and quarantine all on-hand product 3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded. 4. Notify any customers to whom may have distributed or forwarded product affected by this product. 5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributor - 600-635-6021 All other customers - 888-444-5401 For questions regarding this recall call 800-327-7503.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

KKX

Quantity affected

1591 each

Distribution

Worldwide Distribution - US (Nationwide including PR) and Canada

Date initiated

2017-06-27

Date posted

2017-07-07

Date terminated

2019-03-29

Location

Waukegan, IL