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Terminated

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

FDA Recall Z-0163-2022 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2021-07-15
Date Terminated2023-08-11
Product Quantity2 units

Reason for Recall

Two devices were labeled with the same serial number

Firm Action

The firm notified the consignee by email on 07/15/2020 and requested the return of the units.

Root Cause

Process control

Distribution Pattern

UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123957PNEUPAC PARAPAC PLUSSmiths Medical International , Ltd. · 2013-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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