Z-1104-2015Class II
Aquapak Sw/eau Sterile, 650 Ml W/adaptor
Teleflex Medical / initiated 2015-01-14 / Terminated / root cause: manufacturing process
Teleflex Medical began a recall of AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a... on . FDA classified it as Class II and gives the reason as "The packages may contain foreign material (black particles)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1104-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Teleflex Medical
- Product
- AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
- Product code
- BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
- Reason for recall
- The packages may contain foreign material (black particles).
- Root cause tag
- manufacturing process
- FDA root cause
- Material/Component Contamination
- Action
- 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.
- Quantity in commerce
- 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, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
- Product codes and lots
- Product Code: 006-40C, Lot numbers: 040136, 062136, 029136, 013146, 083146, 178136, 048136, 171136, 074136, 104136, 020146, 060136, 039146, 035136 & 087136.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1095-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1096-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1097-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1098-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1099-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1100-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1101-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1102-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1103-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1104-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1105-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1106-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1107-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1108-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1109-2015 | Class II | Terminated | Voluntary: Firm initiated |
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