FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring Sy
Summary
The FDA issued a Class I for FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the Fre by Abbott Diabetes Care, Inc.. Reason: Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter include.
Details
Source
Device Recall
External ID
Z-1273-2023
Action Date
2023-04-12
Status
Ongoing
Category
device
Product Description
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
Lot/Code Info: REF/UDI-DI/Lot: 71525-01/357599000219/02Y702D, 01Y699D, 02Y699D, 01Y698D, 02Y697D, 04Y690D, 03Y690D, 01Y683D, 02Y683D, 01Y674D, 02Y672D, 01Y669D, 02Y666D, 01Y659D, 02Y658D, 02Y656D, 04Y655D, 01Y655D, 01Y652D, 02Y653D, 03Y653D, 03Y651D, 01Y641D, 02Y638D, 01Y637D, 02Y635D, 01Y629D, 03Y628D, 01Y628D, 02Y628D, 02Y621D, 02Y622D, 02Y620D, 02Y608D, 04Y608D, 01Y608D, 01Y603D, 03Y599D, 04Y600D, 02Y596D, 06Y596D, 03Y596D, 07Y547D, 07Y546D, 08Y546D, 05Y540D, 06Y538D, 05Y537D, 03Y536D, 04Y523D, 02Y522D, 02Y519D, 02Y512D, 01Y512D, 01Y511D, 02Y510D, 01Y505D, 02Y504D, 04Y355D, 02Y355D, 01Y352D, 01Y349D, 03Y348D, 01Y348D, 02Y348D, 01Y339D, 01Y335D, 02Y334D, 02Y335D, 03Y314D, 01Y313D, 02Y312D, 01Y312D, 02Y311D, 01Y311D, 02Y310D, 04Y310D, 02Y307D, 03Y307D, 01Y304D, 02Y303D, 02Y304D; 71701-01/357599000226/01Y702D, 01Y694D, 03Y693D, 02Y686D, 03Y683D, 02Y574D, 01Y563D, 02Y563D, 01Y564D, 03Y562D, 01Y552D, 02Y552D, 06Y550D, 05Y539D, 05Y538D, 06Y537D, 01Y536D, 01Y532D, 02Y531D, 03Y522D, 02Y518D, 02Y511D, 01Y508D, 02Y505D, 04Y356D, 01Y356D, 02Y356D, 01Y321D, 01Y320D, 02Y320D, 01Y317D, 02Y317D; 71739-01/357599000240/03Y754D, 03Y734D, 01Y705D, 01Y671D
Quantity Affected: 336,085
Reason for Recall
Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-13
Company
Alameda, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 130 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott Diabetes Care, Inc. has 18 FDA actions in our database, including 10 recalls and 8 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Diabetes Care, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Diabetes Care, Inc. have FDA actions?
Abbott Diabetes Care, Inc. has 18 FDA actions in our database, including 10 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1273-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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