Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, t…
Covidien, LP · Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Open FDA's page for this record- Cfres ID
- 207293
- Product res number
- Z-1891-2024
- Event date initiated
- 2024-04-15
- Event date posted
- 2024-05-24
- Recall status
- Open, Classified
- Res event number
- 94484
- Product code
- GDW
- Code info
- GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
- Firm FEI number
- 1219930
- Recalling firm
- Covidien, LP
- Address 1
- 60 Middletown Ave
- City
- North Haven
- State
- CT
- Postal code
- 06473-3908
- Additional info contact
- Kati Salefski 508-452-4894
- Reason for recall
- Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
- Root cause description
- Under Investigation by firm
- Product quantity
- 1681 units
- Product description
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
- Action
Medtronic issued Urgent Medical Device Recall letter on 4/15/24 via UPS 2-day. Letter states reason for recall, health risk and action to take: Customer Actions: " Immediately identify and quarantine all unused Tri-Staple" 2.0 Black Reinforced Intelligent Reload, Model SIGTRSB60AXT, from the specified lot(s) mentioned above. " Return all unused product in your inventory, corresponding to the specified lot(s) mentioned above, to Medtronic as indicated in the enclosed Customer Confirmation Form. Please complete the enclosed Customer Confirmation Form, even if you have no product to return. Pass on this information to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please keep a copy of this letter in your file. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.
- Distribution pattern
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
- K numbers
- K173270
- Harmonized identifiers (openFDA)
- Device name
- Staple, Implantable
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4750
- Device class
- 2
- K number
- K142873, K050610, K132698, K111153, K873748, K140609, K950006, K263461, K051002, K123718, K082396, K111195, K181620, K121510, K173270, K133938, K051301, K100723, K052910, K111111, K983536, K172960, K132581, K062850, K172561, K260196, K843399, K101378, K843034, K132134, K952239, K163698, K201639, K881484, K913139, K060494, K033602, K241630, K090159, K152618 +245 more
- Registration number
- 1064858, 3010684280, 3004111573, 9710649, 3013665681, 3017102971, 1721686, 3005075853, 3011063460, 1218017, 1219930, 3004447686, 1213643, 2134494, 1222928, 3016607092, 2648623, 9616517, 2955842, 1047423, 3016096100, 1928237, 3008388437, 1055236, 3003800159, 3008383115, 2023739, 3005636544, 3007222388, 1423662, 3017636737, 2183469, 1058584, 3013868968, 3018052045, 3003639920, 3015185328, 1450662, 3012428834, 1650907 +118 more
- FEI number
- 3010684280, 3004111573, 3013665681, 3017102971, 1000306139, 1721686, 3005075853, 3011063460, 1218017, 1219930, 3004447686, 1213643, 3016607092, 1000306431, 2648623, 3016096100, 1928237, 3008388437, 3003800159, 3003495548, 3008383115, 1000112877, 2023739, 3005636544, 3007222388, 3017636737, 2183469, 3013868968, 3018052045, 3003639920, 3015185328, 1450662, 3012428834, 3002619738, 3021604067, 3008615487, 3009931872, 3011050570, 3012998149, 1527736 +118 more