The Recall Desk
HighFDA (Devices)·Z-0344-2016·Announced 2015-12-09

Stryker Recalls I.V. Poles Due to Unexpected Retraction Hazard

Stryker is recalling 19,876 I.V. poles because a nonconforming latch housing may cause them to retract unexpectedly while holding medical equipment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (unexpected retraction of medical equipment) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Stryker Medical Division of Stryker Corporation is recalling 19,876 two-stage and three-stage I.V. poles. These stationary, height-adjustable stands are used as optional accessories for specific Stryker beds and stretchers to hold infusion liquids, accessories, and other medical devices. The affected units were distributed between January 7, 2014, and June 24, 2014.

The recall was initiated after a customer complaint identified that some I.V. poles were retracting or lowering from an extended position to a low height unexpectedly. An investigation determined that the I.V. Latch Housing on these units was nonconforming. This defect creates a potential hazard where the suspended I.V. pole may retract unexpectedly, including instances where pumps or bags are attached.

The affected products were distributed worldwide, including the United States (nationwide, DC, and Guam) and numerous international markets such as Canada, the United Kingdom, Germany, and Japan. Consumers and healthcare facilities should identify affected units by checking the specific model and option numbers listed in the recall documentation. Stryker is managing the recall to address the nonconforming latch housing.

The recalled product

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 pare
Manufacturer
Stryker Medical Division of Stryker Corporation
Category
Medical Device — Hospital Furniture / I.V. Poles
Hazard
Affected units
19,876

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Stryker 2-Stage and 3-Stage I.V. Poles distributed on beds
  • stretchers
  • 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
  • 3 Stage IV Pole Assembly 0785-035-300
  • 30"
  • 3 Stage IV Pole Assembly 0785-035-401
  • 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
  • 2 STAGE FE
  • PL 1105-035-338
  • PL 1040-035-338

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · Stryker Medical Division of Stryker Corporation

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