Z-2759-2017 Class II Terminated
FDA device recall Z-2759-2017 was initiated by Smiths Medical ASD Inc. on Dec 9, 2016 and is designated Class II. Reason for recall: The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada. The recall status is terminated (terminated Dec 14, 2017). Affected quantity: 641,070 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 2, 2017
- Initiation Date
- Dec 9, 2016
- Termination Date
- Dec 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 641,070 units
Product Description
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Reason for Recall
The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.
Distribution Pattern
Canada only
Code Information
Lot No.: 010X47, 025X47, 064X46, 079X48, 094X46, 103X46, 108X49, 155X40, 170X47, 173X47, 187X49, 193X45, 208X40, 208X45, 217X46, 224X46, 230X44, 241X40, 268X40, 286X40, 41X065, 41X099, 41X173, 41X221, 41X284, 41X302, 41X366, 41X399, 41X506, 42X047, 42X154, 42X238, 42X266, 42X302, 42X393, 42X505, 431X40, 43X013, 43X099, 43X125, 43X166, 42X259, 43X298, 43X357, 43X424, 43X467, 43X527, 43X549, 44X053, 44X110, 44X169, 44X197, 44X272, 44X359, 44X388, 44X442, 44X493, 44X547, 44X567, 44X596, 44X682, 44X704, 44X714, 45X074, 45X091, 45X142, 45X234, 45X246, 45X260, 45X346, 45X424, 45X538, 46X023, 46X141, 46X181, 46X228, 46X255, 46X429, 46X430, 46X475, 46X490, 46X543, 46X631
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2759-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026