Custom procedure packs recall
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item…
Why was Custom procedure packs recalled?
Gauze sponges contained in custom kits may be flaking or fraying.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 82466, 83411, 82442, 82504, 82497, 82490, 82592, 82582, 82844, 82832, 82876, 82893, 83058, 83139, 83251, 83138, 83257, 83106, 82886, 83135, 83050, 83264, 82879, 83383, 83271, 83583, 83421, 83560, 83273, 83575, 83576, 82847, 83598, 82472, 82417, 82389, 82473, 82427, 82501, 82496, 82507, 82574, 82478, 82469, 82485, 82584, 82588, 82600, 82597, 82593, 82594, 82606, 82828, 82825, 82882, 83033, 82880, 82887, 83048, 83073, 83042, 83124, 83133, 83095, 83132, 83071, 83238, 83254, 83240, 83232, 83244, 82872, 83222, 82831, 83263, 83111, 83267, 83261, 83274, 83258, 83266, 83388, 83424, 83417, 83426, 83415, 83427, 83557, 83536, 83540, 83418, 83581, 83550, 83428, 83579, 83296, 83268, 83752, 82591, 82589, 82640, 82813, 82513, 82596, 83069, 82852, 83252, 83101, 83293, 83392, 83572, 83120, 83584, 83422, 83955, 82399, 82474, 82403, 82492, 82509, 82470, 82465, 82491, 82575, 82576, 82521, 82525, 82481, 82577, 82500, 82601, 82607, 82595, 82605, 82519, 82523, 82603, 82625, 82888, 83045, 82855, 83066, 82849, 83036, 83049, 82890, 83242, 83235, 83115, 83064, 83046, 83118, 83245, 83126, 83377, 83134, 83389, 83127, 83286, 83269, 83398, 83292, 83285, 83366, 83423, 83391, 83136, 83445, 83283, 83561, 83545, 83585, 83589, 83580, 83944, 83771.
- Product
- Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item…
- Recalling firm
- ROi CPS LLC
- Quantity
- 17,700 total kits
- Distribution
- US Domestic Distribution Only: MO, NC, LA and FL.
- Recall date
- January 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)