Z-2045-2009

Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy...

Name: Z-2045-2009 Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy...
Creator: ConvaTec
Published: 2009-07-29
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2009-07-29 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec began a recall of Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy System; Sterile, box contains 15 units... on 2009-07-29. The reason FDA records is "Labeling: The expiration date does not appear on the product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2045-2009
Status: Terminated
Initiated: 2009-07-29
Posted: 2009-09-09
Terminated: 2009-10-02
Recalling firm: ConvaTec Limited
Product: Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy System; Sterile, box contains 15 units; Boehringer Wound Systems, LLC, Norristown, PA 19404 Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Labeling: The expiration date does not appear on the product label.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Urgent Product Recall letters dated 7/29/09, were hand delivered to all direct customers by ConvaTec Sales Reps. Customers were asked to return any unused products to their supplier. The letter also stated that a credit would be issued for the product. Customers are to contact Karen Krenta at the firm's Customer Interaction Center, 1-800-422-8811.
Quantity in commerce: 152 units
Distribution: Nationwide Distribution
Product codes and lots: Lot number 0709101, Exp 9/2009; lot number 0710101, exp 10/2009.

Product code OMP

K061788Class IIBoehringer Laboratories Suction Pump SystemBoehringer Laboratories / cleared 2006-07-11

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)