Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline procedure kits containing defective plastic syringes are being recalled nationwide. The syringes may leak, break, or have other quality issues that could pose a risk to patient health.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. Per severity rubric, Class I recalls score at minimum 4 (Severe). No deaths, serious injuries, or hospitalizations reported in source. Quality issues in syringes pose potential patient health risk.
Plain-English summary
Medline Industries, LP is recalling 1,679,067 units of two procedure kits: the Nephrology Pack (Pack Number DYNJ59089) and the Nerve Block Tray (Pack Number DYNJRA1221A). These kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024. The syringes have been identified with quality issues including leaks, breakage, and other defects that may pose a risk to patient health.
Specific lot numbers affected include Lot 23IBF074 for the Nephrology Pack and multiple lots for the Nerve Block Tray (20IDB255, 22BDA978, 22KDA950, 22LDA146, 23ADB422, 23BDB453, 23IDA424, 23JDB010). These kits have been distributed worldwide, including throughout the United States and international markets.
Healthcare facilities and healthcare providers using these kits should immediately discontinue use of affected products and contact Medline for replacement units or return instructions. Patients should consult their healthcare provider if they have concerns about procedures performed using these kits.
The recalled product
- Product
- Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089; 2) NERVE BLOCK TRAY, Pack Number DYNJRA1221A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kits
- Affected units
- 1,679,067
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)
- DYNJ59089
- Lot Number 23IBF074
- DYNJRA1221A
- Lot Number 20IDB255
- Lot Number 22BDA978
- Lot Number 22KDA950
- Lot Number 22LDA146
- Lot Number 23ADB422
- Lot Number 23BDB453
- Lot Number 23IDA424
- Lot Number 23JDB010
Distribution
Part of a larger recall action
This product is one of 3 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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