HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are des
FDA device recall Z-2190-2013 · posted 2013-09-11 · Terminated
Recall details
- Recalling firm
- HemoCue AB
- Reason for recall
- During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack pouches.
- Action taken
- HemoCue sent an Urgent Field Safety Notice dated July 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine any affected product and Return the Field Safety Notice Verification Form to e-mail: 2013glufsn@hemocue.com or fax 562-668-5794 Customers would be contacted to coordinate return and replacement of the affected microcuvettes. Customers with questions were instructed to call 800-426-7256. For questions regarding this recall call 440-925-3485.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 22,215 boxes of 100 cuvettes distributed in US, 34, 841 distributed outside the US
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to AUSTRALIA, BELGIUM, CANADA, COTE D'IVOIRE, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, IRELAND, ITALY, KENYA, NETHERLAND
- Date initiated
- 2013-07-15
- Date posted
- 2013-09-11
- Date terminated
- 2014-09-02
- Location
- Angelholm, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 (K020935) | Hemocue, Inc. | 2002-04-03 |