Z-1948-2011

DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box)...

Name: Z-1948-2011 DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box)...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2010-12-03
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2010-12-03 / Terminated / root cause: packaging

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102... on 2010-12-03. The reason FDA records is "Product sterility may be compromised due to breach in sterile packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1948-2011
Status: Terminated
Initiated: 2010-12-03
Posted: 2011-04-12
Terminated: 2013-04-02
Recalling firm: DePuy Mitek, Inc.
Product: DePuy Mitek FMS Irrigation Intermediary Tube Without One-way Valve Arthroscopy tubing (100 units/box) (International Distribution Only) Product Code: 281102 Fluid Tissue Management
Product code: HBX Instrument, Cranioplasty Material Forming
Reason for recall: Product sterility may be compromised due to breach in sterile packaging
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 92,000 units (920 boxes/100)
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 codes and lots: Lot Codes: 1060789 1060823 1060838 1060848 1061291 1061292 BBBA1001I BBBA1003D BBBA1003E BBBA1004A BBBA1006F BBBA1007D BBBA1008A BBBA1010A BBBA1011D BBBA1014B BBBA1015R BBBA1018G BBBA1019E

Product code HBX

K951843Class IIRef. 4102Cv Intermediary Tubing, Ref. 4509Cv Sterile Zone KitFuture Medical Systems, Inc. / cleared 1995-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)