FDA Device recall Z-0344-2016
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher
- FDA Device
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher by Stryker Medical Division, citing it was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0344-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-13 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Medical Division |
| Distribution | US |
Product
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X and 1125XE.
Reason
It was identified by a customer complaint that some I.V. poles were retracting/lowering from an extended position to the low height unexpectedly. An investigation was initiated which identified that the I.V. Latch Housing was nonconforming. potential hazards: " Suspended I.V. pole retracts unexpectedly " Suspended I.V. pole retracts unexpectedly with pump/bags attached
Identifiers
| code_info | Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds, stretchers, and in service kits. This product field action…Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds, stretchers, and in service kits. This product field action is limited to I.V. Poles distributed between 01/07/2014 - 06/24/2014. The following I.V. Pole option numbers come affixed to beds and stretchers: Manufacturer Model Number and Product Description 2035-112-010; Head End Left, 2 Stage I.V. Pole 2035-113-011; Head End Right, 2 Stage I.V. Pole 0785-035-101; 26", 2 Stage IV Pole Assembly 0785-035-200; 26", 3 Stage IV Pole Assembly 0785-035-300; 30", 3 Stage IV Pole Assembly 0785-035-401; 30", 2 Stage IV Pole Assembly The following I.V. Pole option numbers ship as service kits. Manufacturer Service Kit Number and Product Description 1105-035-368; 30" IV POLE 2 STAGE HE PR 1105-035-367; 30" IV POLE 2 STAGE HE PL 1105-035-343; 30" IV POLE 2 STAGE FE PR 1105-035-341; 30" IV POLE, 2 STAGE HE, PR 1105-035-340; 30" IV POLE, 2 STAGE FE, PL 1105-035-338; 30" IV POLE, 2 STAGE FE, PL 1040-035-338; 2-STAGE |
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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-0344-2016%22
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