Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. b. Medline Cath Lab Pack, Pack #DYNJ56141A, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile. c. Medline Sterile Loop Insertion Tray, Pack DYNJ62843A, containing a Pure Pouch containing Medline Reorder #DYNJ04048, Kelly Forceps/Std Str Sterile. d. Medline Radiology Minor MVH, Pack #DYNJ63555C, containing a Pure Pouch containing component Sterile Curved Kelly Hemostat, Reorder #66175. e. Medline Basic Pack, Pack #DYNJ80649B, containing a Pure Pouch containing component Medline DYND0400 O.R. Scissors, S/B, 5.5 Sterile.
This recall is currently active, issued June 28, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 14, 2024
- Posted
- June 28, 2024
- Recall Number
- Z-2228-2024
- Quantity
- 12,588 total sterile kits
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
a. Pack #DYNJ47873K - lot numbers 23HBK868, exp. 8/31/2027, 23HBC082exp. 2/29/2028, 23GBC462, exp. 1/31/2028, and 23DBK792, exp. 11/30/2027, UDI-DI each 10193489466812 and UDI-DI case-40193489466813. b. Pack #DYNJ56141A - lot numbers 23IBK595, exp. 1/31/2025, UDI-DI each-10193489555585 and UDI-DI case-40193489555586. c. Pack DYNJ62843A - lot numbers 24ABP043, exp. 12/31/2024, and 23IBM893, exp. 3/31/2025, UDI-DI each-10195327001766 and UDI-DI case-40195327001224. d. Pack #DYNJ63555C - lot numbers 24ALA613, exp. 3/31/2025; 23KLA748, 1/31/2025; 23KLA017, exp. 1/31/2025; 23JLA853, exp. 1/31/2025; 23JLA232. exp. 1/31/2025; 23ILB006, exp. 1/31/2025; 23ILA201, exp. 12/31/2024; and 23HLA429, exp. 12/31/2024; UDI-DI each-10193489816525 and UDI-DI case-40193489816526. e. Pack #DYNJ80649B - lot number 23JBG046, exp. 5/31/2026, UDI-DI each-10195327269944 and UDI-DI case-40195327269945.
Root Cause
Process control
Action Taken
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