Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0369-2024 — Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resuscitator REF #s: CPRM

U.S. FDA — Device Enforcement · United States · 2023-10-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0369-2024
Date of alert
2023-10-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SunMed Holdings, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888277628298
Reported risk: A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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