Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023
This recall is currently active, issued September 6, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- April 8, 2024
- Posted
- September 6, 2024
- Recall Number
- Z-3014-2024
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution
Worldwide distribution.
Lot / Code Info
DYNJRA1023 , Lot Number 21IBW483 ; DYNJRA1023 , Lot Number 22ABH162 ; DYNJRA1023 , Lot Number 19BBA260 ; DYNJRA1023 , Lot Number 19FBP403 ; DYNJRA1023 , Lot Number 19IBY026 ; DYNJRA1023 , Lot Number 19KBX011 ; DYNJRA1023 , Lot Number 20EBK333 ; DYNJRA1023 , Lot Number 20GBU419 ; DYNJRA1023 , Lot Number 20HBS695 ; DYNJRA1023 , Lot Number 20KBF923
Root Cause
Under Investigation by firm
Action Taken
Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.