Medline Procedural Kits Recalled Due to Potential Sterility Specification Failures
Medline Industries is recalling sterile procedural kits containing ultrasound gel that may not meet sterility specifications. The 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 is a Class II medical device recall with no reported illnesses or injuries. The recall addresses potential failure to meet sterility specifications on a component used in invasive procedures, constituting a risk-of-harm product where injury has not yet been reported, consistent with High severity criteria.
Plain-English summary
Medline Industries, LP is recalling sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The affected kits are the CATH LAB PACK (Model DYNJ58351A) and PV CAROTID PACK (Model DYNJ63341B).
The recall was issued because the sterile ultrasound gel component within the kits may not meet sterility specifications. A product labeled and intended to be sterile that fails to meet sterility standards poses a potential health risk when used in invasive medical procedures.
The kits were distributed worldwide from April 1, 2020 through April 28, 2023. Distribution included the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. A total of 624 kits were affected.
Healthcare facilities and users who have received these kits should immediately stop using them and contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ63341B;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kit
- Affected units
- 624
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 (2)
- UPC Number: 088827773939. b. Model Number: DYNJ63341B
- UPC Number: 019348995809.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 50 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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