Medline Procedural Kits Recalled for Potential Sterility Failure
Medline is recalling 13,881 sterile procedural kits worldwide due to potential sterility failure in the ultrasound gel component. The affected kits are used in various medical insertion procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall for a potential sterility defect in medical device components used for insertion procedures. No illnesses or injuries have been reported. Per the rubric, this represents a risk-of-harm medical device where injury has not yet been reported, corresponding to severity score 3.
Plain-English summary
Medline Industries, LP is recalling 13,881 custom sterile and non-sterile procedural kits containing Turkuaz Ultrasound Gel. The recalled kits include eight model types used in various medical insertion procedures: CVC Infant Insertion Pack (CVI4770A), Insertion Bundle (DT21275), Midline Dressing Change Kit (EBSI1464), Midline Insertion Kit (DT20155), PICC Line Dressing Tray (DT22045), Universal Dressing & PPE Kit (DT22065), and VA Maintenance Pack (EBSI1382).
The kits are being recalled because the labeled sterile ultrasound gel component may not meet sterility specifications. Using these kits could potentially result in non-sterile conditions during medical insertion procedures.
The recalled kits were distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of the affected models distributed between April 1, 2020, and April 28, 2023, are included in this recall.
Healthcare facilities and clinicians should discontinue use of these kits. Contact Medline Industries for replacement kits and further instructions.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Hazard
- Affected units
- 13,881
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)
- UPC Number: 10653160350828. b. Model Number: DT21275
- UPC Number: 10653160318934. c. Model Number: EBSI1464
- UPC Number: 10193489198959. d. Model Number: DT20155
- UPC Number: 10653160290070. e. Model Number: DT22045
- UPC Number: 10653160325659. f. Model Number: DT22065
- UPC Number: 065316032660. g. Model Number: DT22065
- UPC Number: 10653160326601. h. Model Number: EBSI1382
- UPC Number: 10193489196269.
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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