Z-1620-2008

FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound...

Name: Z-1620-2008 FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound...
Creator: Smith And Nephew, Inc. Wound Management Division
Published: 2008-03-31
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-03-31 / Terminated / root cause: labeling and UDI

FDA source

Smith And Nephew, Inc. Wound Management Division began a recall of FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who... on 2008-03-31. The reason FDA records is "Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain". 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-1620-2008
Status: Terminated
Initiated: 2008-03-31
Posted: 2008-08-06
Terminated: 2008-11-18
Recalling firm: Smith & Nephew, Inc.
Product: FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.
Product code: BTA Pump, Portable, Aspiration (Manual Or Powered)
Reason for recall: Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified of recall by letter (Correction and Removal Notification) sent to customers on 3/31/08. They were asked to check their stocks, identify, and return all affected units to Smith & Nephew according to the instructions. Consignees are to contact the Customer Care Center at 1-800-876-1261, if they have additional questions.
Quantity in commerce: 4796
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: 517141, 517269, 517143, and 517108

Product code BTA

K042134Class IIVersatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated / cleared 2004-11-01

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)