The synthetic non-absorbable surgical sutures CARDIOFLON Evolution… — Class II medical device recall Z-2676-2014
Terminated recall by Peters Surgical, reported 2014-10-01, distributed nationwide. A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identif
| Recall number | Z-2676-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Peters Surgical, Bobigny, N/A, France |
| Recall initiated | 2014-06-25 |
| Classified | 2014-09-22 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2017-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, CH, CN, CY, CZ, DE, DO, DZ, EG, ES, FR, GB, HU, ID, IE, IL, IT, JP, KR, LB, LK, MA, MY, NL, NZ, PE, PK, PL, RO, RU, SA, TH, TW, VE, VN, ZA |
| Quantity | 22,190 units |
| UPC / GTIN / UDI-DI | 03661522034118, 03661522034125, 03661522034262, 03661522034279, 03661522034286, 03661522034323, 03661522034347, 03661522034354, 03661522034392, 03661522034415, 03661522034439, 03661522034446, 03661522034460, 03661522034477, 03661522034538, 03661522034552, 03661522034576, 03661522034590, 03661522034606, 03661522034675, 03661522034910, 03661522034989, 03661522035009, 03661522035061, 03661522037492 and 3 more |
| Lot numbers | 1008710, 1009510, 1011370, 1135, 1485, 1486, 1487, 1872, 2192, 2195, 2440, 2480, 3403, 3995, 4370, 4371, 4372, 4920, 4974, 5021, 5136, 5158, 5508, 5557, 6222, 6554, 7057, 7627, 942350, 942400, 942420, 942500, 942510, 942530, 942580, 942670, 942720, 942760, 942910, 942940 and 23 more |
| Expiration dates | 2018-02, 2018-03, 2018-04, 2018-05, 2018-06, 2018-07, 2018-08, 2018-09, 2018-10, 2019-01, 2019-02, 2019-03, 2019-04 |
Product
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).
Reason for recall
A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2676-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.