The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2675-2014·Announced 2014-10-01

Peters Surgical Recalls CARDIOXYL Sutures Due to Surface Treatment Splitting

Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic surgical sutures because a potential splitting of the surface treatment on thread ends was identified.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific hospitalizations or severe injuries are reported in the source text.

Plain-English summary

Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic non-absorbable surgical sutures. The recall was initiated after a potential splitting of the surface treatment on the thread ends of certain sutures was identified. The affected products are composed of polyester braids, with or without PLEDGET, and are coated with polysiloxane.

The recall covers specific batches of CARDIOXYL sutures, including item references 73P20B, 73P30AA, 73P30AG, 73P30AI, 73P30AM, 73P30AN, 73P30BQ, 73P30CN, 73P30CR, 73P30D, 73P30E, 73P30F, 73P30O, 73P30P, 73P30Q, 73P30R, 73P30T, 73P30U, 73P30V, 73P30Y, 73P35E, 73S10H, 73S30AE, and 73S30AT. The affected units were distributed nationwide in the United States and to numerous countries worldwide, including Algeria, Argentina, Australia, and the United Kingdom.

Healthcare providers and consumers should check their inventory for the specific batch numbers and expiration dates listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

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…
Manufacturer
Peters Surgical
Category
Medical Device — Surgical Sutures
Hazard
Affected units
4,976

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) Item reference: 73P20B
  • Batch number: 1902
  • Expiration date: 09/2018
  • GTIN on box label: 3661522016527
  • 2) Item reference: 73P20B
  • Batch number: 987180
  • Expiration date: 07/2018
  • 3) Item reference: 73P20B
  • Batch number: 997390
  • Expiration date: 08/2018
  • 4) Item reference: 73P30AA
  • Batch number: 932870
  • Expiration date: 02/2018
  • GTIN on box label: 3661522016701
  • 5) Item reference: 73P30AG
  • Batch number: 931880
  • Expiration date: 12/2017
  • GTIN on box label: 3661522029510
  • 6) Item reference: 73P30AG
  • Batch number: 932880

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Peters Surgical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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