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DePuy Mitek FMS Irrigation Intermediary Tube With One-way… recallZ-1946-2011 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Dec 3, 2010

Terminated All recalls posted in April 2011

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 DePuy Mitek, Inc., a Johnson & Johnson Co. 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

Product sterility may be compromised due to breach in sterile packaging

FDA root cause category: Packaging process control

What the company is doing

Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.

Recall details

Recall number
Z-1946-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 3, 2010
Posted by the FDA
Apr 12, 2011
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
50,376 units
Product code
HBX
FDA submissions
K951843
Distribution
Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.

Product description

DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management

Code information (models, lots, serial numbers)

Lot Codes: 1060792 1060824 1060841 1060851 BBBA0953D BBBA0953E BBBA0953F BBBA0953G BBBA1001T BBBA1001V BBBA1002H BBBA1002I BBBA1005D BBBA1005E BBBA1005F BBBA1005G BBBA1007J BBBA1008C BBBA1008E BBBA1010G BBBA1010H BBBA1010J BBBA1010K BBBA1012B BBBA1012C BBBA1012E BBBA1014A BBBA1014E BBBA1015F BBBA1015G BBBA1018E BBBA1018F BBBA1020B BBBA1020C

Other devices under the same FDA submission

6 devices cleared under K951843 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 57385).

Sources and updates

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