Facility

Wyeth Pharmaceuticals LLC

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3004393730
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	500 Arcola Road Collegeville, PA, US 19426
Registration status	Active · expires 2026
Parent company	PFIZER INC. (owner-operator 9924008)
Brand names	GEL-FLOW NT; Gel-Flow Kit 6mL

Activity by year

Recalls (3)

Devices registered here (1)

Agent, Absorbable Hemostatic, Collagen Based
Product code LMF (opens in a new tab) · Class III · General, Plastic Surgery · 21 CFR 878.4490

Recalls & enforcement

Class IITerminated2018-10-02
The firm received complaints of the wrap coming apart and leaking granular material
Class IITerminated2016-12-30
Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an …
Class IITerminated2016-07-28
Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Wyeth Pharmaceuticals LLC (FEI 3004393730) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004393730-wyeth-pharmaceuticals-llc/

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