Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1,

FDA device recall Z-1235-2020 · posted 2020-02-03 · Terminated

Recall details

Recalling firm

Cardinal Health 200, LLC

Reason for recall

The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.

Action taken

Urgent Medical Device Recall notification letters dated 1/31/20 were distributed to customers. Actions Required: 1. CHECK all storage and usage locations to confirm if you have any units of the affected item codes and lot numbers in your possession per enclosed report identifying your facilitys packs. Exhibit A outlines how to identify affected packs and the lot number. 2. SEGREGATE and QUARANTINE all packs on-hand that are confirmed to be affected by lot number per attached report identifying your facilitys packs. 3. RETURN the enclosed acknowledgment form either by facsimile (614-495-5651) or email (GMBCardinalSurgicalGownRecall@ cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined. Please respond even if you are not affected by this recall. 4. NOTIFY any customers to whom you may have distributed or forwarded product affected by this recall. You may include a copy of this recall notice with your customer notification. 5. CONTACT the appropriate Cardinal Health Customer Service group, Mondays Fridays between 8 AM and 11 PM EST, to arrange for return and credit/replacement of affected product: Hospital (800) 964-5227 Federal Government (800) 444-1166 Distributor (800) 635-6021 All Other Customers (888) 444-5440 6. CUSTOMERS that did not receive affected packs directly from Cardinal Health should return them through the location where they purchased them. In the event you have experienced quality problems or adverse events related to the affected packs, contact the appropriate Cardinal Health Customer Service group listed in #5 above. URGENT MEDICAL DEVICE RECALL notification letter for EVENT #: 2020-02735 Presource Packs dated February 25, 2020. Upon further review, Cardinal Health is initiating an expansion to the Presource Procedure Pack recall for specific lots of Presource Packs produced between September 1, 2018 and February 19, 2020. Our records indicate you may have receiv

Root cause

Vendor change control

Status

Terminated

Product code

LRO

Quantity affected

2,161,526 units (113, 711 additional units as of 2/25/20)

Distribution

US Nationwide.

Date initiated

2020-01-31

Date posted

2020-02-03

Date terminated

2023-01-19

Location

Waukegan, IL