The Recall Desk
ModerateFDA (Devices)·Z-2763-2015·Announced 2015-09-23

Med Tec Recalls CIVCO Shoulder Retractors Due to Excessive Strap Length

Med Tec Inc is recalling CIVCO Shoulder Retractors because the wrist straps used for patient positioning are too long.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The defect involves straps that are too long, which is a functional issue that could compromise patient positioning but does not explicitly report injuries or hospitalizations, fitting the Moderate criteria for a Class II recall without severe injury reports.

Plain-English summary

Med Tec Inc is recalling 18 sets of CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070. The recall is due to a defect where the wrist straps used for positioning the patient are too long.

The affected product is used in patient positioning, specifically for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area. The recall includes lot numbers M765570 and M784310.

The product was distributed worldwide, including in the United States (specifically NE, SC, and KS) and foreign countries such as Australia, China, Venezuela, Spain, Turkey, and Hong Kong. Users should stop using the affected devices and contact Med Tec Inc for further instructions.

The recalled product

Product
CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in
Manufacturer
Med Tec Inc
Affected units
18

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 (1)

  • Lot numbers M765570 and M784310.

Distribution

Distributed in 3 states: