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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72466

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 13, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker Medical Division of Stryker Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0344-2016
Recall number
Z-0344-2016
Initiated
October 13, 2015
Classification
Class II
Status
Terminated
Quantity
19,876

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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

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

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.