FDA Device recall Z-1105-2015
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o…
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water o… by Teleflex Medical, citing the packages may contain foreign material (black particles).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1105-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-14 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. 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.
Reason
The packages may contain foreign material (black particles).
Identifiers
| code_info | Product Code: 006-40F, Lot numbers: 147136, 103146, 015146, 102136, 153136, 023146, 040146, 001146, 056146, 115136, 052…Product Code: 006-40F, Lot numbers: 147136, 103146, 015146, 102136, 153136, 023146, 040146, 001146, 056146, 115136, 052146, 132136, 008146, 110136, 159136, 165136 & 014146. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1105-2015%22
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