FDAFDA · Food and drugs·Recall number Z-1873-2017
Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
Published April 26, 2017 · Recall initiated: January 8, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Laerdal Medical Corporation
- Distributor
- Nationwide
- Lot
- Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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