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Class 2 Device Recall Medline |
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| Date Initiated by Firm |
March 14, 2024 |
| Date Posted |
June 28, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2231-2024 |
| Recall Event ID |
94239 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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| Product |
Non-sterile convenience kits:
Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. |
| Code Information |
Pack #CDS981759C - Lot numbers 24ADA460, exp. 7/31/2025; 23KDB724, exp. 7/31/2025; 23JDA205, exp. 10/31/2025; 23IDA683, exp. 11/30/2025; and 23EDA124, exp. 5/31/2025; UDI-DI each-10888277524002 and UDI-DI case-5/31/2025.
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact |
Karin Johnson
886-359-1704
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Manufacturer Reason
for Recall |
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
|
FDA Determined
Cause 2 |
Process control |
| Action |
The recalling firm issued two different letters on and dated 3/14/2024 via first class mail and email. One of the letters was for the recall of the non-sterile kits and the other letter was flagged as a Safety Alert for the sterile kits.
The recall letter for the non-sterile kits explained the issue of the Pure Pouches (which is the packaging for a sterile component) contained within the kits have been found to have weak seals which may not be detectable to the user. This would result in a breach of sterility of the component within the Pure Pouch. The hazard of the sterility breach was explained and required actions were listed which were: (1) Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal and quarantine all affected product immediately; (2) Use the login link and the information in the letter to complete the response form. List the quantity of affected product in inventory on the form, regardless of whether or not it is in inventory, and submit the form; (3) Upon receipt of the response form, the account will receive over-labels to place on affected inventory with instructions for the staff to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight; and (4) If the account is a distributor or has resold or transferred this product to another company or individual, the account is to notify them of this recall communication.
The letter regarding the sterile kits was flagged as a safety alert and explained the issue of the Pure Pouches contained within the kits have weak seals. The letter went onto say that despite the Pure Pouch having a weak seal, the kit lots were sterilized in a Medline-validated ethylene oxide (EO) process that renders the component(s) within the Pure Pouch sterile. Medline stated they are issuing this safety alert to reiterate that the kit is single-use only. In the event the affected components are not |
| Quantity in Commerce |
7,673 total non-sterile kits |
| Distribution |
US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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