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Z-0179-2020 Class II Terminated

Recalled by Andover Healthcare Inc. — Salisbury, MA

FDA device recall Z-0179-2020 was initiated by Andover Healthcare Inc. on June 19, 2019 and is designated Class II. Reason for recall: Incomplete packaging seal of sterile product The recall status is terminated (terminated September 9, 2020). Affected quantity: 1798 Cases.

Recall Details

Product Type: Devices
Report Date: October 30, 2019
Initiation Date: June 19, 2019
Termination Date: September 9, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1798 Cases

Product Description

Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

Reason for Recall

Incomplete packaging seal of sterile product

Distribution Pattern

US Nationwide distribution including the states of MA, TX, RI, OH, NY, MN, SD, IL, MO, FL, VA, NE, UT, CA

Code Information

Manufacturer's product or Catalog # 5300S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0ST7, CI0ZJT, CI17BA, CI18Y6, CI1HM0

Other recalls by Andover Healthcare Inc.

Z-1828-2024 Class II — Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) (April 2, 2024)
Z-0182-2020 Class II — Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)
Z-0184-2020 Class II — Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)
Z-0180-2020 Class II — Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or co (June 19, 2019)
Z-0183-2020 Class II — Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)
Z-0181-2020 Class II — Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or c (June 19, 2019)