Medical convenience kits with syringes recalled due to quality issues
Medline Industries is recalling Centurion procedure packs containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The syringes may have leaks, breakage, or other quality issues that could pose a health risk.
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: Classified as FDA Class II, the defective syringes present a risk-of-harm to patients. However, no illnesses, injuries, or deaths have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a Score 3 (High).
Plain-English summary
Medline Industries, LP is recalling Centurion procedure packs containing plastic syringes. The recalled kits are used for various medical procedures including biopsies, circumcisions, lumbar punctures, and ultrasound-guided placement of intravenous lines.
The plastic syringes in these kits are subject to an FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified in these syringes that may pose a risk to patient health.
The affected products have been distributed worldwide. Specific lot numbers have been identified for each affected kit type.
The recalled product
- Product
- Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leaks
- breakage
- 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 (11)
- SPEC4380
- Lot Number 2023092590
- CIT6325
- Lot Number 2023082990
- CIT6785A
- Lot Number 2022120190
- Lot Number 2023021790
- Lot Number 2023041290
- PT215
- MNS9580
- ECVC8050
Distribution
Distribution scope not specified by the agency.
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