Reported Nov 6, 2024 · Ongoing

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD…

Smiths Medical ASD Inc.

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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following
CADD Solis Ambulatory Infusion Systems
183 of 183 codes
- 21-2101-0100-50
- 21-2101-0200-02
- 21-2101-0200-03
- 21-2101-0200-06
- 21-2101-0200-07
- 21-2101-0200-12
- 21-2101-0200-14
- 21-2101-0200-17
- 21-2101-0200-238
- 21-2101-249
- 21-2101-51
- 21-2102-0200-02
- 21-2102-249
- 21-2102-51
- 21-2111-0100-00
- 21-2111-0100-50
- 21-2111-0100-51
- 21-2111-0200-02
- 21-2111-0200-03
- 21-2111-0200-06
- 21-2111-0200-07
- 21-2111-0200-08
- 21-2111-0200-12
- 21-2111-0200-14
- 21-2111-0200-17
- 21-2111-0200-232
- 21-2111-0200-50
- 21-2111-0300-00
- 21-2111-0300-01
- 21-2111-0300-02
- 21-2111-0300-03
- 21-2111-0300-06
- 21-2111-0300-07
- 21-2111-0300-08
- 21-2111-0300-09
- 21-2111-0300-12
- 21-2111-0300-14
- 21-2111-0300-17
- 21-2111-0300-231
- 21-2111-0300-232
- 21-2111-0300-50
- 21-2111-0400-01
- 21-2111-0400-51
- 21-2111-0401-02L
- 21-2111-0401-03L
- 21-2111-0401-06L
- 21-2111-0401-07
- 21-2111-0401-07L
- 21-2111-0401-08L
- 21-2111-0401-12L
- 21-2111-0401-14L
- 21-2111-0401-17L
- 21-2111-0401-249
- 21-2111-0401-51
- 21-2111-0401-51L
- 21-2111-0401-78
- 21-2111-0402-02
- 21-2111-0402-02L
- 21-2111-0402-03L
- 21-2111-0402-06L

Lot codes and dates: All serial numbers.
Amount recalled: 138039 units

Why it was recalled

Stop using this product now

Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.

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

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By hazard

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CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Oct 30, 2024
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PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM… Sep 4, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses… Aug 14, 2024
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b)… Apr 24, 2024

60 in total.

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