Medline Medical Convenience Kits Recalled for Syringe Quality Defects
Medline medical convenience kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The FDA Safety Alert issued March 19, 2024, identifies affected syringes used in multiple types of medical procedures.
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 recall involves risk-of-harm medical devices with actual identified defects (leaks and breakage in syringes used in clinical procedures) where no injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Medline Industries has recalled medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The affected kits are used in labor and delivery, fetal surgery, gynecological procedures, and robotic surgery.
The FDA Safety Alert issued on March 19, 2024, identified defects in the plastic syringes included in these convenience kits. The defects include leaks, breakage, and other quality issues that may pose a risk to patient health during the procedures for which these kits are intended.
The recall affects Medline convenience kits with worldwide distribution. Affected kits are identified by specific pack numbers beginning with "CDS" or "DYN" prefixes and corresponding lot numbers listed in the FDA recall notice. Healthcare facilities should identify any affected units in their inventory using the pack and lot numbers specified and discontinue use of affected products.
Individuals who have undergone procedures using these convenience kits should consult their healthcare provider if they have concerns about their care. Healthcare facilities should contact Medline Industries or the FDA for information about product returns, replacements, or other remediation options.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6)
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- syringe-leak
- syringe-breakage
- quality-defect
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)
- CDS830039AD
- Lot Number 19CBH292
- Lot Number 19PBC608
- CDS840214P
- Lot Number 21FBN852
- Lot Number 21HBB376
- Lot Number 21HBF491
- Lot Number 21IBO111
- Lot Number 22ABD314
- Lot Number 22BBI956
- Lot Number 22HBP289
- Lot Number 22IBO308
- Lot Number 22IBR971
- Lot Number 22KBN497
- Lot Number 20JBQ048
- Lot Number 20KBG189
- Lot Number 20KBY177
- Lot Number 21BBC946
- CDS981335C
- Lot Number 21GBL170
Distribution
Distribution scope not specified by the agency.
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