Recall Z-2229-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated March 14, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nonsterile convenience kits: a. Medline Delivery, Pack #DYNJ901130I, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile. b. Medline C-Section, Pack DYNJ902938J, containing a Pure Pouch with component Reorder #DYND04000, O.R. Scissors, S/B, 5.5 Sterile.
Codes / lots: a. Pack #DYNJ901130I - Lot numbers 23GMH075, exp. 7/31/2024, and 23GMD605, exp. 7/31/2024, UDI-DI each-10193489946055 and UDI-DI case-40193489946056. b. Pack DYNJ902938J - Lot numbers 23LMD530, 23IMG375, 23HMB336, 23GMF342, 23EMJ935, and 23EMK254, all exp. date 8/31/2024, UDI-DI each-10193489946116, UDI-DI case 40193489946117.
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: 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
Details
- Recall number
- Z-2229-2024
- Initiated
- March 14, 2024
- Posted by FDA
- June 28, 2024
- Product code
- MLS – Labor And Delivery Kit
- Quantity
- 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.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2224-2024 Class II | Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2225-2024 Class II | Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2226-2024 Class II | Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2227-2024 Class II | Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2228-2024 Class II | Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2230-2024 Class II | Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2231-2024 Class II | Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |
| Z-2232-2024 Class II | Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B…Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach… | 03/14/2024Open, Classified |