Medline Paracervical Pudendal Block Kits Recalled for Syringe Quality Issues
Medline is recalling Paracervical Pudendal Block kits because the included plastic syringes have leaks, breakage, or other quality issues that may risk patient health.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with identified quality defects (leaks, breakage) that pose a risk to patient health, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Paracervical Pudendal Block kits (Pack Number DYNJRA1023) due to quality issues with the plastic syringes included in the kits. The recall is related to an FDA Safety Alert issued on March 19, 2024, which identified leaks, breakage, and other quality issues in the syringes that may pose a risk to patient health.
The affected products are distributed worldwide. Specific lot numbers involved in this recall include 21IBW483, 22ABH162, 19BBA260, 19FBP403, 19IBY026, 19KBX011, 20EBK333, 20GBU419, 20HBS695, and 20KBF923.
Healthcare providers and consumers should stop using these kits and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- DYNJRA1023
- Lot Number 21IBW483
- Lot Number 22ABH162
- Lot Number 19BBA260
- Lot Number 19FBP403
- Lot Number 19IBY026
- Lot Number 19KBX011
- Lot Number 20EBK333
- Lot Number 20GBU419
- Lot Number 20HBS695
- Lot Number 20KBF923
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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