Pilling Wecksorb Neurosponges Surgical Sponges Recalled for Endotoxin Contamination

Plain-English summary

Teleflex LLC is recalling multiple catalog numbers of Pilling Wecksorb Neurosponges (Cotton) and Pilling Wecksorb Neurosponge Strips (Cotton). The sponges are made of absorbent cotton material, with some varieties featuring x-ray detectable thread or strings for surgical accountability. These devices are used during cranial and spine surgery to moisten tissue, cushion against bone, and protect brain and central nervous system tissue during surgical procedures.

The recall is due to out-of-specification or potentially out-of-specification levels of endotoxins in the devices. Endotoxins are bacterial contaminants that may pose a risk to patients during surgical use. The affected products were distributed nationwide across the United States and to Panama.

Healthcare facilities and surgical centers that have received these products should stop using them immediately and contact Teleflex LLC for replacement or further instructions. Patients who have undergone surgery with these sponges prior to the recall should consult their healthcare provider if they have any concerns.

For more information, consumers and healthcare professionals can contact the FDA or visit the FDA's medical device database using the recall number Z-2639-2026.

The recalled product

Product

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software V

Manufacturer

TELEFLEX LLC

Category

Medical Device — Surgical / Neurosurgical Sponges

Hazard

• endotoxin
• bacterial-contamination

Is your product affected?

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

Distribution

Distributed nationwide across the United States.

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