Facility

ROCKET MEDICAL PLC

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

Key facts

2recalls · 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)	3002808026
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	Sedling Road WASHINGTON Sunderland, GB NE38 9BZ
Registration status	Active · expires 2026
Parent company	Rocket Medical Plc (owner-operator 8010022)
Brand names	Heimlich Valve; IPC Bottles and accessories; Pleural Vent

Activity by year

Recalls (2)

Devices registered here (1)

Bottle, Collection, Vacuum
Product code KDQ (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6740

Recalls & enforcement

Class IIOngoing2025-11-07
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Class IITerminated2019-08-01
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.

All facilities operated by Rocket Medical Plc

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. “ROCKET MEDICAL PLC (FEI 3002808026) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808026-rocket-medical-plc/

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