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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78302

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

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Event summary

Timeline bucket
September 27, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
WalkMed, LLC

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.

How coverage and grouping work

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

Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is intended to be used as a reservoir and fluid path for administering intravenous, subcutaneous, arterial, enteral, and epidural infusions of antibiotics, analgesics, chemotherapeutic agents, and other medications or fluids. Please note that the WalkMed 350VL pump is contraindicated for: Infusion of blood and blood products, Infusion of insulin, Infusion of critical medications whose stoppage or interruption would cause serious injury or death Use in ambulatory regimens by patients who do not possess the mental, physical, or emotional capability to operate the pump properly; or who are not under the care of a responsible individual.

Z-0090-2018
Recall number
Z-0090-2018
Initiated
September 27, 2017
Classification
Class II
Status
Terminated
Recalling firm
WalkMed, LLC
Quantity
25,920 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.

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

There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.

Code information

20717525, 20717529, 20817502, 20817503, 20717509, 20717511, 20717512, 20717517, 20817500, 20717530

Distribution pattern

Nationwide Distribution