Reported Apr 10, 2013 · Terminated

Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of…

Animas Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Animas Corporation · 200 Lawrence Dr · West Chester, PA · 19380-3428

Is this the product you have?

Animas(R) 2020
Insulin Infusion Pump Product UsageThis product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes

Lot codes and dates: Part Numbers 101370-00
101371-00
101372-00
101374-00
101375-00
100380-00
100381-00
100382-00
100384-00
and 100385-00
Serial Numbers
494 of 494 codes
62-00202-12
36-97839-12
01-05118-12
25-02849-12
63-99894-12
80-00093-12
37-04692-12
92-04130-12
27-99281-12
32-99198-12
81-00513-12
44-02998-12
46-99680-12
23-02928-12
03-04500-12
01-03079-12
79-00261-12
26-99273-12
16-03650-12
93-03219-12
12-02808-12
21-04715-12
34-98485-12
40-98917-12
19-03646-12
27-00988-12
09-02900-12
28-99437-12
96-05032-12
03-00908-12
25-98448-12
15-02913-12
33-99713-12
91-00632-12
71-01130-12
07-05064-12
15-00948-12
92-02246-12
36-98399-12
97-00740-12
75-00229-12
32-01986-12
80-02118-12
97-04135-12
26-00899-12
20-03654-12
44-99495-12
31-99285-12
23-01970-12
43-99575-12
48-99499-12
83-00191-12
11-00768-12
31-99461-12
88-02066-12
88-00189-12
34-02974-12
24-02950-12
54-99790-12
96-03067-12
Amount recalled: 7,157 (494 US pumps affected)

Where it was sold

Why it was recalled

Stop using this product now

Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pumps. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following: - Loss of prime; -Occlusion; or -No cartridge detected.

Using this product could cause serious injury, illness or death — stop using it now.

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Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of…

What you should do

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Where it was sold

Why it was recalled

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Where it was sold

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