The Recall Desk
HighFDA (Devices)·Z-2336-2023·Announced 2023-08-09

Medline Procedural Kits Recalled Due to Sterility Specification Concerns

Medline Industries is recalling 211 custom procedural kits (egg retrieval, fetal surgery, TVT packs) worldwide because the sterile ultrasound gel component may not meet sterility specifications. Kits were distributed 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: FDA Class II recall of sterile medical device components where sterility specifications may not be met. The hazard is potential non-sterility in surgical/procedural equipment. No illnesses or injuries have been reported, placing this at High rather than Severe per the rubric.

Plain-English summary

Medline Industries is recalling 211 custom procedural kits containing Turkuaz ultrasound gel. The affected products include the EGG RETRIEVAL PACK (Model DYNJ66291B), FETAL SURGERY CDS-LF (Model CDS840214P), and TVT PACK SMGH-LF (Model DYNJ41913C).

The FDA Class II recall has been issued because the sterile ultrasound gel component within these kits has the potential to not meet sterility specifications. No illnesses or injuries have been reported.

The affected kits were distributed worldwide between April 1, 2020 and April 28, 2023. Distribution included the United States nationwide as well as Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates.

Healthcare providers and facilities that have received these kits should contact Medline Industries immediately for instructions on return, replacement, or proper disposal. Check product packaging for the affected model and lot numbers, which include all lots of the three models distributed during the specified time period.

The recalled product

Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG RETRIEVAL PACK, Model Number: DYNJ66291B; b. FETAL SURGERY CDS-LF, Model Number: CDS840214P; c. TVT PACK SMGH-LF, Model Number: DYNJ41913C;
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/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: 019532715117. b. Model Number: CDS840214P
  • UPC Number: 019348944319. c. Model Number: DYNJ41913C
  • UPC Number: 019348967757.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category