Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0234-2020 — SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/b

U.S. FDA — Device Enforcement · Germany · 2019-08-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0234-2020
Date of alert: 2019-08-30
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Pajunk GmbH
Product category: device
Product type: Devices

Reported risk: Problem with packaging sealing process which affects sterility.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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