Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

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.

Urgent Medical Device Correction 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 packs and lot numbers per enclosed report identifying your facilitys packs. 2. ALERT your clinicians of this action including Exhibit A and B. 3. SEGREGATE and QUARANTINE all Presource Procedure Packs on-hand that are confirmed to be affected by lot number, if not already completed, per enclosed report identifying your facilitys packs. 4. AFFIX a WARNING LABEL as outlined in Exhibit A and included with this notice to the front of each Presource pack so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s) as well as any other componentry NOT contained within an inner, sealed packaging separating the product from contacting the affected gown. All components within inner, sealed packaging or other packs within the sterilization pouch may be used. Refer to Exhibit B for detailed instructions. Note: Additional labels can be sent to your facility upon request. Please email GMBCardinalSurgicalGownRecall@ cardinalhealth.com for assistance. 5. RETURN the enclosed acknowledgment form either by facsimile (614-495-5651) or email (GMBCardinalSurgicalGownRecall@ cardinalhealth.com) confirming your receipt of this action and the completion of the labeling product. Please respond even if you are not affected by this medical device correction notice. 6. NOTIFY any customers to whom you may have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this recall notice with your customer notification. 7. CONTACT Presource Sales Operations at (800) 766-0706 or your sales representative if you do not wish to accept overlabeled product or overlabel the product in your possession. For component credit or replacement, please contact the followi