VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60… recallZ-0139-04 · Merit Medical Systems, Inc · initiated Oct 1, 2003

Terminated All recalls posted in November 2003

Is my device affected?

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.
If yours is listed, follow the instructions from Merit Medical Systems, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
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

There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.

FDA root cause category: Other

What the company is doing

Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.

Recall details

Recall number: Z-0139-04
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: Oct 1, 2003
Posted by the FDA: Nov 19, 2003
Recalling firm: Merit Medical Systems, Inc
Quantity: 287 units
Product code: FMF
FDA submissions: K994253
Distribution: Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.

Product description

VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''. Sterile if package is unopened or undamaged. Part #VAC160.

Code information (models, lots, serial numbers)

Lot # A282003

Other devices under the same FDA submission

1 device cleared under K994253 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Syringe Kit - Stroke MVSK60
Microvention, Inc. · Syringe, piston
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.

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