Medline Recalls Procedural Kits Over Sterility Specification Failure
Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.
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: FDA Class II recall of sterile medical devices with failure to meet sterility specifications. While no illnesses or injuries have been reported, this represents a risk-of-harm situation in procedural kits used in sensitive medical procedures where sterility is critical.
Plain-English summary
Medline Industries, LP is recalling approximately 9,319 custom sterile and non-sterile procedural kits that contain Turkuaz Ultrasound Gel. The recalled kits include Fetal Intervention kits (models DYNJ66041A, DYNJ66041B), Fetal Intervention Packs (models DYNJ62319A, DYNJ62319B), Ultrasound PIV Kits (model DYNDV2397), VAD Access kits (model DYNJ24276C), and Vaginal Delivery Trays (model DYNJ27275).
The ultrasound gel component is labeled as sterile but may not meet sterility specifications. This poses a potential risk when these kits are used in medical procedures.
The affected kits were distributed worldwide, including across the United States, Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. All lot numbers of the affected models distributed from April 1, 2020, through April 28, 2023, are included in this recall.
Healthcare facilities and providers using these procedural kits should discontinue use immediately and contact Medline Industries for instructions on return or disposal of affected products.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedural Kits
- Affected units
- 9,319
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 (9)
- UPC Number: 019348948028
- Model Number: DYNJ66041B
- UPC Number: 019532715107. b. Model Number: DYNJ62319A
- UPC Number: 019348947486
- Model Number: DYNJ62319B
- UPC Number: 019348999548. c. Model Number: DYNDV2397
- UPC Number: 019348938846. d. Model Number: DYNJ24276C
- UPC Number: 088438943118. e. Model Number: DYNJ27275
- UPC Number: 008019683311.
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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