Skip to content

Medline procedure packs containing Shenli syringes, labeled… recallZ-2631-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Apr 8, 2024

Class II Open, Classified All recalls posted in August 2024

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Recall details

Recall number
Z-2631-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 8, 2024
Posted by the FDA
Aug 27, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1,679,067 units in total
Product code
LRO
FDA submissions
K213481
Distribution
Worldwide distribution.

Product description

Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045

Code information (models, lots, serial numbers)

ECVC8105, Lot Number 2023052690; ECVC8105, Lot Number 2023100490; ECVC8045, Lot Number 2023110990

Other devices under the same FDA submission

321 devices cleared under K213481 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page