Medline C-Section Convenience Kits Recalled for Syringe Quality Issues
Medline is recalling C-section convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes may leak or break, posing 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: The recall is classified as FDA Class II, and the source states the defects 'may pose a risk to patient health' without reporting specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling specific C-section convenience kits and trays. These kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024. The recall covers numerous pack numbers and lot numbers, including C-SECTION TRAY, C-SECTION CDS, and C-SECTION PACK variants.
The recall is due to identified leaks, breakage, and other quality issues with the plastic syringes included in the kits. These defects may pose a risk to patient health. The source text does not specify the number of affected units or the specific geographic distribution beyond noting that the kits are medical convenience kits.
Healthcare facilities and consumers should check their inventory for the affected pack and lot numbers listed in the official recall notice. If you have these specific kits, do not use the plastic syringes contained within them. Contact Medline Industries or your medical supply provider for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B ; 2) C-SECTION TRAY, Pack Number AM160C ; 3) C-SECTION CDS , Pack Number CDS820031I ; 4) C-SECTION CDS , Pack Number CDS820031J ; 5) C-SECTION PACK, Pack Number CDS820081K ; 6) C-SECTION PACK, Pack
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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)
- AM160B
- Lot Number 19DBG798
- Lot Number 19DBT073
- Lot Number 19GBK115
- Lot Number 19TBB002
- Lot Number 19IBN286
- Lot Number 19KBF062
- AM160C
- Lot Number 21FBM171
- Lot Number 20ABB878
- Lot Number 20BBW406
- Lot Number 20CBA975
- Lot Number 20DBD025
- Lot Number 20GBG950
- Lot Number 20HBV795
- Lot Number 21BBF298
- Lot Number 21BBF425
- CDS820031I
- Lot Number 19BBK847
- Lot Number 19CBE063
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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