FDA Medical Device Recalls (openFDA)
Southmedic Inc: Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
- Recall number
- Z-1190-06
- Recalling firm
- Southmedic Inc
- Product
- Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
- Status
- Terminated
- Initiated
- 2006-04-21
- Posted
- 2006-07-04
- Terminated
- 2012-03-06
- Reason
- Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
- Root cause
- Other
- Action
- Recall letters were sent to both US consignees via US Postal Service delivery with signature receipt required on April 21, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Southmedic. U.S. and international consignees were instructed to examine inventory immediately to identify if they have any product on hand, discontinue the distribution of these products and return all affected products to Southmedic. Consignees were also instructed to immediately notify their customers if they have further distributed these products.
- Quantity
- 186 in US (403 Worldwide)
- Distribution
- US in FL & NJ Worldwide in Australia, Belgium, Ecuador, Germany, Japan, Netherlands, Sri Lanka, Taiwan, & United Arab Emerates
- Lot, serial or model codes
- Lot Numbers: S07275, S02086, S10215, S08315, S02286, S12095, S12195, S12215, S02216, & S03096
- 510(k) numbers
- ["K945993"]
- PMA numbers
- not on file
- Product code
- CAD
- Firm FEI
- 3001717360
- Firm city
- Barrie Canada
- Firm state
- Ontario
- 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