Medline procedural kits recalled due to defective plastic syringes
Medline is recalling procedural kits with defective syringes due to leaks and breakage that may pose patient health risks. Affected products include biopsy packs, circumcision trays, and breast biopsy kits.
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 is an FDA Class II medical device recall. The defective syringes with leaks and breakage present a risk-of-harm product; with no reported injuries, this meets the High severity (3) criterion.
Plain-English summary
Medline Industries is recalling five models of procedural kits distributed worldwide. The affected products include biopsy packs (Pack Number DYNJ63370A), circumcision trays (Pack Numbers CIT7210 and DYNDA2271, including Mercy Medical and UCLA-branded versions), and breast biopsy kits (Pack Number DYNDH1512A).
The kits contain plastic syringes affected by an FDA Safety Alert from March 19, 2024. These syringes exhibit leaks, breakage, and other quality issues that may pose a risk to patient health.
Healthcare facilities and medical professionals using these kits should consult the specific lot numbers associated with each product to identify affected units. Individuals with questions should contact Medline Industries or the FDA.
The recalled product
- Product
- Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural 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 (8)
- 1) DYNJ63370A
- Lot Number 23IMB164
- 2) CIT7210
- Lot Number 2022101890
- 3) DYNDA2271
- Lot Number 2023090790
- 4) CIT6780
- 5) DYNDH1512A
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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