Medical Procedural Kits Recalled Due to Ultrasound Gel Sterility Risk
Medline Industries is recalling 1,182 sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications. The affected kits were distributed worldwide between April 2020 and April 2023.
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 product presents a risk of harm because the ultrasound gel component may not be properly sterilized, potentially introducing contamination during medical procedures. However, no illnesses or injuries have been reported, making this a High severity per FDA Class II standards.
Plain-English summary
Medline Industries is recalling custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The affected products include three models: CATH LAB BASIN PACK (DYNJ69864A), DELNOR VASCULAR BASIN PACK (DYNJ82257), and FLAP PACK (DYNJ60224C). In total, 1,182 kits are involved in this recall.
The ultrasound gel component labeled as sterile in these kits may not meet sterility specifications. This means the gel may not be properly sterilized, presenting a contamination risk when the kits are used in medical procedures.
The recalled kits were distributed worldwide, including throughout the United States and internationally to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers for the affected models distributed between April 1, 2020, and April 28, 2023, are included in the recall.
Healthcare providers and medical facilities that have received these kits should contact Medline Industries for instructions regarding this recall.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DELNOR VASCULAR BASIN PACK, Model Number: DYNJ82257; c. FLAP PACK, Model Number: DYNJ60224C;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- sterility-failure
- contamination-risk
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 (3)
- UPC Number: 019532713205. b. Model Number: DYNJ82257
- UPC Number: 019532718165. c. Model Number: DYNJ60224C
- UPC Number: 019532715184.
Distribution
Distributed nationwide across the United States.
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