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FDA Medical Device Recalls (openFDA)

Vital Concepts, Inc.: Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Recall number
Z-0260-04
Recalling firm
Vital Concepts, Inc.
Product
Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
Status
Terminated
Initiated
2003-11-07
Posted
2004-07-20
Terminated
2004-09-13
Reason
The probe may separate from the cannula.
Root cause
Other
Action
Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
Quantity
70
Distribution
Arizona, Illinois, Indiana, Michigan and Pennsylvania.
Lot, serial or model codes
lot 994986.
510(k) numbers
["K934382"]
PMA numbers
not on file
Product code
BYY
Firm FEI
1000115375
Firm city
Grand Rapids
Firm state
MI
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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