Medline Procedural Kits Recalled for Defective Plastic Syringes
Medline Industries is recalling multiple procedural kits containing plastic syringes affected by an FDA Safety Alert. The syringes have quality issues including leaks and breakage that may pose a risk to patient health.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II medical device recall involves quality defects in syringes with potential risks to patient health but no reported illnesses or injuries. Per the severity rubric, recalls with theoretical hazards and no adverse events score at most 3 (High).
Plain-English summary
Medline Industries, LP is recalling multiple surgical and procedural kits containing plastic syringes that were identified through an FDA Safety Alert issued on March 19, 2024. The recalled kits include anterior segment packs, arthrogram trays, arthroscopy kits for various joints (hip, knee, shoulder), orthopedic spine packs, lumbar drain packs, and other specialty surgical procedure kits.
These kits have been distributed worldwide across numerous lot numbers. The plastic syringes included in the kits have quality issues, including leaks, breakage, and other defects that may pose a risk to patient health. No patient illnesses or injuries have been reported to date.
The recalled product
- Product
- Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6)…
- 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)
- DYNJ63330B
- Lot Number: 23KMB339
- DYNJ82317
- Lot Number: 23JMD184
- DYNDH1446A
- Lot Number: 21LBY820
- Lot Number: 22GBD333
- Lot Number: 22JBR587
- Lot Number: 23FBP838
- Lot Number: 23GBR825
- Lot Number: 23HBU128
- Lot Number: 23IBD510
- Lot Number: 23JBY402
- Lot Number: 24ABN001
- Lot Number: 24BBU148
- Lot Number: 21BBP451
- Lot Number: 21BBQ361
- DYNDH1648
- Lot Number: 24CBI888
- PAIN1396
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 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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