Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut hydrocolloid-coated polyureth
FDA device recall Z-0483-2015 · posted 2014-12-01 · Terminated
Recall details
- Recalling firm
- Beevers Manufacturing & Supply, Inc.
- Reason for recall
- Cannulaide recalled May 2008 due to improper seal of the pouch. The improper seal of the Cannulaide's package could potentially affect the device shelf life.
- Action taken
- Beevers Manufacturing & Supply, Inc. (BMS) did contact the customers via letter and phone call in May 2008. Customers that didn't reply were further contacted via email on June 2008. Salter Labs provided BMS' recall report to FDA in October 2014. Salter Labs was unable to locate a recall letter issued by BMS to the affected customers. For further questions please call (503) 472-9055
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- BZD
- Quantity affected
- 16,575 units total (15,625 units in US and 950 units outside US)
- Distribution
- Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.
- Date initiated
- 2008-05-13
- Date posted
- 2014-12-01
- Date terminated
- 2014-11-28
- Location
- McMinnville, OR
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