Medline Procedural Kits Recalled Due to Defective Plastic Syringes
Medline is recalling multiple procedural kits containing defective plastic syringes that may leak or break. The syringes were identified in an FDA Safety Alert issued on March 19, 2024.
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: FDA Class II recall without reported illnesses or injuries. The defective syringes present a potential risk to patients during procedures, but no actual harm has been documented. Per the rubric, recalls with theoretical hazards and no reported injuries score at most 3 (High).
Plain-English summary
Medline Industries, LP is recalling four types of medical procedural kits: Circumcision Tray (Pack Number CIT6715), NICU Circumcision Tray Without Clamp (Pack Number CIT6920), Port Dressing Change Tray (Pack Number DT18415), and UCLA Breast Biopsy Kit (Pack Number DYNDH1512). These kits contain plastic syringes that have been identified as defective.
The plastic syringes in these kits were included in an FDA Safety Alert issued on March 19, 2024. Quality issues with the syringes, including leaks, breakage, and other defects, have been identified that may pose a risk to patient health during medical procedures.
The affected kits have been distributed worldwide. Healthcare facilities and providers should stop using affected lots and contact Medline Industries, LP or the FDA for instructions on replacement or proper disposal.
The recalled product
- Product
- Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural kits
- Hazard
- leakage
- breakage
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 (17)
- CIT6715
- Lot Number 2023011090
- CIT6920
- Lot Number 2021081890
- DT18415
- Lot Number 22OBA722
- Lot Number 22JBQ737
- Lot Number 23BBE570
- Lot Number 23DBS680
- Lot Number 23EBS516
- Lot Number 23HBN856
- Lot Number 23JBV086
- Lot Number 21BBF570
- Lot Number 21CBO659
- Lot Number 24CBM583
- DYNDH1512
- Lot Number 2021120690
Distribution
Distribution scope not specified by the agency.
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