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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Twostage and threestage I.V. poles

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  Class 2 Device Recall Stryker Twostage and threestage I.V. poles see related information
Date Initiated by Firm October 13, 2015
Create Date November 30, 2015
Recall Status1 Terminated 3 on September 06, 2016
Recall Number Z-0344-2016
Recall Event ID 72466
Product Classification Stand, infusion - Product Code FOX
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.
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 
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Stryker Customer Service
800-327-0770
Manufacturer 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
FDA Determined
Cause 2		 Process control
Action On 10/13/2015, URGENT MEDICAL DEVICE NOTIFICATION letters were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Our normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).
Quantity in Commerce 19,876
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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