Medline Tonsil and Adenoid Surgical Kits Recalled for Syringe Defects
Medline is recalling Tonsil & Adenoid surgical convenience kits containing defective plastic syringes. The kits may leak or break, posing risks to patient safety.
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: This is a Class II medical device recall with theoretical risk of harm from defective syringes that may leak or break during medical procedures. No illnesses or injuries have been reported in the source text, placing it in the 'High' category per the rubric's criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Tonsil & Adenoid surgical convenience kits (Pack Number DYNJ43427C) due to defective plastic syringes. The syringes are affected by an FDA Safety Alert issued on March 19, 2024, and have been identified with quality issues including leaks and breakage that may pose a risk to patient health.
The affected kits have worldwide distribution, with multiple lot numbers spanning production dates from 2019 through 2023.
Healthcare providers and organizations should review this recall and contact Medline Industries or the FDA for instructions and further information. See FDA recall number Z-3000-2024 for additional details.
The recalled product
- Product
- Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
- 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 (20)
- DYNJ43427C
- Lot Number 21HBA933
- Lot Number 22ABL557
- Lot Number 22BBL591
- Lot Number 19ABE939
- Lot Number 19ABM274
- Lot Number 19ABT846
- Lot Number 22DBL373
- Lot Number 22FBV273
- Lot Number 22GBE783
- Lot Number 22HBY245
- Lot Number 22IBS212
- Lot Number 19IBD112
- Lot Number 22KBT930
- Lot Number 22KBV623
- Lot Number 19JBZ344
- Lot Number 23ABM258
- Lot Number 23CBQ295
- Lot Number 23DBQ887
- Lot Number 23EBQ116
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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