Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385; c) PEDIATRIC CENTRAL LINE KIT, Model Number DYNJ38885B; d) CENTRAL LINE TRAY, Model Number DYNJ42902B; e) CENTRAL LINE PACK - COMPANION, Model Number DYNJ47215D; f) PICC LINEPACK (PCLUI)642-LF, Model Number DYNJ47717A; g) PK CUST CENTRAL LINE PACK, Model Number DYNJ60586; h) TUNNEL LINE PACK, Model Number DYNJ67990; i) CLOSURE PACK, Model Number DYNJ83054A
FDA Recall Z-2184-2023 · Posted 2023-07-20
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Reason for Recall
Firm Action
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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