ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o
FDA device recall Z-1107-2015 · posted 2015-02-12 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The packages may contain foreign material (black particles).
- Action taken
- Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- BTT
- Quantity affected
- 15,779,607 units
- Distribution
- Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malays
- Date initiated
- 2015-01-14
- Date posted
- 2015-02-12
- Date terminated
- 2017-12-04
- Location
- Research Triangle Park, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUAPAK 020 HUMIDIFIER ADAPTER (K833974) | Respiratory Care, Inc. | 1983-12-16 |