Integra LifeSciences Corp. recalls Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek shee…

Recall date

August 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2907-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

Nationwide Distribution to KS only

Why it was recalled

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage