Recall Z-2229-2024 ยท MLS Labor And Delivery Kit
MEDLINE INDUSTRIES, LP - Northfield
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.
| Date | Jun 28, 2024 (initiated Mar 14, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 e |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.