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Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. ...

FDA Device Recall #Z-0344-2016 — Class II — October 13, 2015

Recall Summary

Recall Number Z-0344-2016
Classification Class II — Moderate risk
Date Initiated October 13, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Medical Division of Stryker Corporation
Location Portage, MI
Product Type Devices
Quantity 19,876

Product Description

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 for Recall

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

Distribution Pattern

Worldwide Distribution-US (nationwide) including DC and Guam, and the countries of New Zealand Canada Chile Hong Kong Colombia Argentina Brazil France Germany Italy Netherlands Spain Switzerland United Kingdom India Japan South Korea Mexico South Africa Poland Singapore.

Lot / Code Information

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 IV POLEHEAD LT30" ZM 0785-035-340; 2-STAGE IV POLE,HEAD LT, 30" 0785-035-341; 2-STAGE IV POLEHEAD RT 30" 0785-035-343; 2-STAGE IV POLE,FOOT RT, 30" 1105-035-344; 30" IV POLE, 3 STAGE FE, PL 1105-035-342; 30" IV POLE, 3 STAGE HE, PL 1105-035-339; 30" IV POLE, 3 STAGE FE, PR 1105-035-369; 30" IV POLE, 3 STAGE HE, PL 1105-035-366; 30" IV POLE, 3 STAGE HE, PR 0785-035-339; 3-STAGE IV POLE,FOOT RT, 30" 0785-035-342; 3-STAGE IV POLE,HEAD LT, 30" 1105-035-644; 26" IV POLE, 3 STAGE FL 1105-035-642; 26" IV POLE, 3 STAGE HL 1105-035-639; 26" IV POLE 3 STAGE FR 1105-035-637; 26" IV POLE, 3 STAGE HR 0785-035-637; 3-STAGE IV POLE,HEAD RT, 26" 0785-035-639; 3-STAGE IV POLE,FOOT RT, 26" 0785-035-642; 3-STAGE IV POLE,HEAD LT, 26" 1105-035-643; 26" IV POLE, 2 STAGE FR 1105-035-641; 26" IV POLE, 2 STAGE HR 1105-035-640; 26" IV POLE, 2 STAGE FL 1105-035-638; 26" IV POLE, 2 STAGE HL 0785-035-638; 2-STAGE IV POLE,HEAD LT, 26" 0785-035-640; 2-STAGE IV POLE,FOOT LT, 26" 0785-035-641; 2-STAGE IV POLE,HEAD RT, 26" 0785-035-643; 2-STAGE IV POLE,FOOT RT, 26" 2035-112-000; IV POLE - 2 STAGE H/E 2035-113-000; DUAL H/E 2 STAGE IV POLE OPT

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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