FDA Device recall Z-2253-2012
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND
- FDA Device
- Class I
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class I recall of ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND by I Flow, citing it was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2253-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-08 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | I Flow |
| Distribution | n/a |
Product
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367. Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.
Reason
It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. As a result, the patient may receive continuous infusion at a rate greater than expected.
Identifiers
| code_info | Products having a 10-digit Lot # that is greater than 0200521454 (i.e. 0200521455 and greater) are not impacted by this recall. |
|---|
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-2253-2012%22
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