The Recall Desk

FDA (Devices) recall action 69997

Med Tec Inc recalled 2 products on 2015-01-21

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-01-21
Critical
0
Units
13

Why these products were recalled

The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Devices)··2015-01-21

    Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

    Med Tec Inc is recalling specific wool wrist loops for shoulder retractors because they were manufactured 7cm shorter than specifications.

    Product
    Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to…
    Category
    Distribution
    4 states
  • LowFDA (Devices)··2015-01-21

    Med Tec Recalls Short Wool Wrist Loops for Shoulder Retractors

    Med Tec Inc is recalling 11 units of a wool wrist loop component for shoulder retractors because the items were manufactured 7cm shorter than specifications.

    Product
    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
    Category
    Distribution
    4 states