Medline procedural kit syringes recalled for leaks and breakage
Medline Industries is recalling multiple surgical procedural kits containing plastic syringes with quality defects. The syringes may leak or break during use, posing a risk to patient safety.
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: FDA Class II device recall involving potential device failure during surgical procedures. No illnesses or injuries have been reported; the hazard is theoretical but in a high-risk surgical context.
Plain-English summary
Medline Industries, LP is recalling multiple surgical procedural kits that contain plastic syringes affected by an FDA Safety Alert issued on March 19, 2024. These kits were distributed worldwide.
The recalled syringes have been identified with quality defects including leaks and breakage. These defects may pose a risk to patient health if they occur during surgical procedures.
Affected kits include models for open heart, vascular, carotid endarterectomy, and other cardiac and vascular surgical procedures, with numerous lot numbers identified in the recall.
The recalled product
- Product
- Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN HEART, Pack Number CDS983348AA; 4) OPEN HEART, Pack Number CDS983348X; 5) OPEN HEART, Pack Number CDS983348Y; 6) HMT CV SET UP CDS…
- 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)
- CDS981050Q
- Lot Numbers : 23IBJ172
- CDS982411N
- Lot Numbers : 23IBH624
- Lot Numbers : 23IBI963
- CDS983348AA
- Lot Numbers : 23FBN637
- Lot Numbers : 24ABM288
- Lot Numbers : 24ABR888
- CDS983348X
- Lot Numbers : 22GBA977
- Lot Numbers : 22KBB264
- CDS983348Y
- Lot Numbers : 23BBR849
- Lot Numbers : 23CBM949
- Lot Numbers : 23DBB694
- CDS984206R
- Lot Numbers : 22GBP993
- Lot Numbers : 22HBU408
- Lot Numbers : 22KLA374
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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