Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tu
FDA device recall Z-1189-06 · posted 2006-07-04 · Terminated
Recall details
- Recalling firm
- Southmedic Inc
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAD
- Quantity affected
- 69 in US (211 Worldwide)
- Distribution
- US in FL & NJ Worldwide in Australia, Belgium, Ecuador, Germany, Japan, Netherlands, Sri Lanka, Taiwan, & United Arab Emerates
- Date initiated
- 2006-04-21
- Date posted
- 2006-07-04
- Date terminated
- 2012-03-06
- Location
- Barrie Canada, Ontario
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAPOFIL (K945993) | Southmedic, Inc. | 1995-02-22 |