Class II — Peters Surgical
| Recalling firm | PETERS SURGICAL INTERNATIONAL CO., Ltd |
|---|---|
| Registered facility | PETERS SURGICAL INTERNATIONAL CO., LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. |
| Product | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL 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. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a suppo… |
| Quantity | 4,976 units |
| Distribution | Worldwide Distribution- US: Nationwide (CA, FL, GA, IL, IN, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, TX, VA, WA); and countries: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, CAMBODIA, CHINA, CYPRUS, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, LEBANON, LIBYA, MALAYSIA, MAURITIUS, MOLDOVA, MORO… |
| Initiated | 2014-06-25 |
| Classified | 2014-09-22 |
| Terminated | 2017-12-13 |
| Recall number | Z-2675-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Peters Surgical (Z-2675-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68721/
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