Z-0360-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2016
- Initiation Date
- November 7, 2014
- Termination Date
- November 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,748,000 units
Product Description
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Reason for Recall
Tubing detachment
Distribution Pattern
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Code Information
5038783, 5040464, 5042582, 5042584, 5043414, 5043415, 5046638, 5046639, 5047168, 5049122, 5052903, 5052904, 5056680, 5057219, 5057241, 5057953, 5060205, 5061496, 5063694, 5064402, 5068516, 5068555, 5071403, 5072333, 5073682, 5075554, 5076349, 5043121, 5044843, 5057215, 5064141, 5068515, 5035649, 5035690, 5039578, 5039579, 5039580, 5039581, 5040158, 5040159, 5040465, 5040466, 5040467, 5040468, 5042578, 5042580, 5042581, 5043094, 5043095, 5043100, 5043106, 5043387, 5043417, 5043418, 5043419, 5046393, 5046395, 5046396, 5046640, 5046641, 5047170, 5047171, 5047510, 5047511, 5047580, 5047581, 5047582, 5049123, 5050034, 5050035, 5050036, 5051560, 5051561, 5051562, 5052905, 5052906, 5053786, 5053787, 5053788, 5054558, 5054559, 5055496, 5055497, 5056681, 5056682, 5057047, 5057221, 5057226, 5057231, 5057232, 5057242, 5057243, 5057251, 5057954, 5057955, 5060206, 5060207, 5060208, 5060946, 5060947, 5060948, 5060949, 5060988, 5060989, 5063695, 5063696, 5064142, 5064143, 5064144, 5064145, 5065089, 5065090, 5065106, 5066445, 5066513, 5066514, 5066524, 5067182, 5067183, 5067587, 5067589, 5067590, 5068518, 5068520, 5068522, 5070664, 5072716, 5072717, 5075402, 5075403, 5075555, 5075556, 5075557, 5076350, 5077461, 5077462, 5078949, 5053658, 5064299, 5032640, 5039582, 5039589, 5040469, 5041195, 5043329, 5043420, 5043421, 5046397, 5047172, 5047175, 5047583, 5049124, 5050037, 5051563, 5052907, 5053661, 5056683, 5057244, 5058702, 5058704, 5059523, 5059551, 5059552, 5060209, 5060950, 5061497, 5063697, 5064403, 5066515, 5067184, 5067592, 5068528, 5071405, 5072347, 5072718, 5075404, 5075558, 5077463, 5038779, 5032646, 5040470, 5040471, 5041196, 5043112, 5043114, 5043422, 5043423, 5044841, 5047177, 5047584, 5050038, 5051564, 5052908, 5055463, 5055465, 5056684, 5057245, 5060210, 5060951, 5060952, 5060990, 5067185, 5067593, 5068526, 5070666, 5071406, 5072719, 5075405, 5077464, 5078950, 5057216, 5032652, 5040472, 5040473, 5043117, 5043425, 5043426, 5043427, 5046644, 5046645, 5047179, 5049125, 5053789, 5055498, 5058706, 5058708, 5059553, 5060953, 5060991, 5066516, 5068531, 5070667, 5071407, 5072631, 5076348, 5076353, 5077465, 5039586, 5040474, 5072633, 5079671, 5038787, 5043124, 5043428, 5043429, 5053790, 5064146, 5064404, 5068530, 5068557, 5072634