Reported Jan 17, 2018 · Terminated

UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z,…

King Systems Corp. dba Ambu, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: King Systems Corp. dba Ambu, Inc. · 15011 Herriman Blvd · Noblesville, IN · 46060-4253

Lot codes and dates: 552 of 552 codes
1960762
1960765
1960769
1960784
1960787
1960788
1960789
1960792
1960800
1960803
1960804
1961934
1961935
1961936
1961937
1961938
1961940
1961941
1961942
1961943
1961945
1961946
1961951
1961952
1961953
1961956
1961957
1961960
1962253
1962254
1962256
1962260
1962261
1962263
1962264
1962265
1962266
1962359
1962360
1962366
1962368
1962596
1962609
1962612
1962613
1962614
1962615
1962849
1962852
1962853
1962855
1962890
1962891
1962892
1962893
1962895
1964378
1964379
1964380
1964381
Amount recalled: 871,116 units

Potential for leak test failures.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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