Medline medical convenience kits recalled for syringe leaks and breakage
Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to 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: This FDA Class II recall involves medical device defects in syringes with no reported illnesses or injuries. Score 3 (High) applies under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling multiple lots of medical convenience kits containing plastic syringes with identified quality defects. The affected syringes may experience leaks, breakage, or other quality issues that pose a potential risk to patient health.
The recalled convenience kits are used in obstetric and gynecological procedures, including labor and delivery operations. These products have been distributed worldwide. The recall affects numerous package and lot number variants of Medline medical convenience kits.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CD
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- syringe-leak
- syringe-breakage
- device-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)
- AM185B
- Lot Number 23BBS790
- Lot Number 23IBT868
- Lot Number 23JBW874
- Lot Number 24ABQ730
- CDS830039AF
- Lot Number 19GBO514
- Lot Number 19HBS937
- Lot Number 19JBM007
- Lot Number 19VBF341
- Lot Number 20ABQ286
- Lot Number 20BBR820
- Lot Number 20CBC115
- Lot Number 20EBC561
- Lot Number 20FBH160
- Lot Number 20GBG417
- Lot Number 20GBT038
- Lot Number 20JBA496
- Lot Number 20LBV774
- Lot Number 21ABJ105
Distribution
Distribution scope not specified by the agency.
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