Z-1189-06

Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic...

Name: Z-1189-06 Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic...
Creator: Southmedic Inc
Published: 2006-04-21
License: https://open.fda.gov/license/

Southmedic Inc. / initiated 2006-04-21 / Terminated

FDA source

Southmedic Inc began a recall of Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from... on 2006-04-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1189-06
Status: Terminated
Initiated: 2006-04-21
Posted: 2006-07-04
Terminated: 2012-03-06
Recalling firm: Southmedic Inc.
Product: Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer.
Product code: CAD Vaporizer, Anesthesia, Non-Heated
Reason for recall: 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.
FDA 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 in commerce: 69 in US (211 Worldwide)
Distribution: US in FL & NJ Worldwide in Australia, Belgium, Ecuador, Germany, Japan, Netherlands, Sri Lanka, Taiwan, & United Arab Emerates
Product codes and lots: Lot numbers : I02156, I07205, I03096, I02286, & I12095

Product code CAD

K945993Class IIVapofilSouthmedic, Inc. / cleared 1995-02-22

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)