Z-1814-2009

ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only...

Name: Z-1814-2009 ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only...
Creator: ConvaTec
Published: 2009-07-13
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2009-07-13 / Terminated / root cause: labeling and UDI

FDA source

ConvaTec began a recall of ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code... on 2009-07-13. The reason FDA records is "Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched". 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-1814-2009
Status: Terminated
Initiated: 2009-07-13
Posted: 2009-09-29
Terminated: 2009-10-02
Recalling firm: ConvaTec Limited
Product: ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Recall notification letters were hand delivered on July 13, 2009 to all direct customers (tier 1) by ConvaTec reps. Letters were provided to all direct customers so that they could notify all customers that received the product.
Quantity in commerce: 764
Distribution: Nationwide distribution and ConvaTec sales rep in the UK and France.
Product codes and lots: Product Order # 44650, Lot number 0902102.

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)