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CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable… recallZ-0124-2010 · Med Tec Inc · initiated Aug 31, 2009

Terminated All recalls posted in November 2009

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 Med Tec Inc 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

Some of the packages contain the incorrect mask style.

FDA root cause category: Process control

What the company is doing

The recalling firm initiated their recall via letter dated 8/27/09 issued certified mail for the domestic customers and e-mail for the foreign customer. The communication informs the customer of the reason for recall and offers to replace the product. For questions or for return of the mask, a phone number is provided. A response form was enclosed with the letter for completion to indicate the amount of affected product in the possession of the customer and whether or not they plan to return it.

Recall details

Recall number
Z-0124-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 31, 2009
Posted by the FDA
Nov 6, 2009
Recalling firm
Med Tec Inc
Quantity
12 boxes
Product code
IYE
FDA submissions
K933227
Distribution
Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.

Product description

CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.

Code information (models, lots, serial numbers)

Lot M121560

Other devices under the same FDA submission

1 device cleared under K933227 — 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

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