FDA Device recall Z-0836-2018
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile by Stryker, citing routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0836-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-17 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker |
| Distribution | n/a |
Product
STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
Reason
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Identifiers
| code_info | a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061…a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0836-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.