The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0779-2020·Announced 2020-01-15

Medical Action Industries Recalls Medical Convenience Kits Due to Saline pH Defect

Medical Action Industries is recalling 9,924 cases of medical convenience kits because the included saline solution may exceed USP pH requirements.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a deviation from USP pH specifications, which is a quality control issue without confirmed harm, fitting the criteria for a moderate severity score.

Plain-English summary

Medical Action Industries, Inc. is recalling 9,924 cases of medical convenience trays and kits. The affected products include various central line, laceration, tracheostomy, and wound care kits manufactured by Medical Action Industries, Medichoice, and Therapy Supply House. The recall covers specific lot numbers distributed to facilities in 21 states, including Massachusetts, Rhode Island, Pennsylvania, Maryland, Virginia, North Carolina, South Carolina, Georgia, Florida, Kentucky, Ohio, Indiana, Michigan, Illinois, Missouri, Nebraska, Louisiana, Texas, Arizona, California, and Washington.

The recall was initiated because the kits contain a bottle of saline solution which may exceed the USP specified pH requirements of 4.5-7.0. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare facilities and consumers should check their inventory for the specific reference numbers and lot numbers listed in the official recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit…
Manufacturer
Medical Action Industries, Inc. 306
Category
Medical Device — Medical Convenience Kits
Hazard
Affected units
9,924

Is your product affected?

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

Lot numbers (14)

  • ***CVC*** Clear Sequence Change Kit
  • VCU
  • REF 57647B Lot Numbers: 0000249224 0000248261 Central Line Removal Kit
  • REF 78631B Lot Numbers: 0000258405 0000264395 Chest Tube Cleaning Kit
  • REF 80643D Lot Numbers: 0000263867 Dressing Change Kit
  • REF 71538 Lot Numbers: 256205 0000256888 ED Suture Set
  • REF 59806B Lot Numbers: 0000250817 0000252940 0000253601 Laceration Tray
  • REF 59387 Lot Numbers: 0000248176 0000247839 Laceration Tray
  • REF 69477B Lot Numbers: 0000256510 0000261832 0000263335 Laceration Tray
  • REF 72347 Lot Numbers: 0000250772 0000248306 LACERATION/SUTURE REMOVAL
  • REF 78197 Lot Numbers: 0000262582 0000263685 Suture Kit
  • Kit de Traqueostomia
  • REF LH_68162B Lot Numbers: 0000256422 0000258614 Trach Care Tray
  • Reorder # 76512B Lot Numbers: 0000252929 0000254713

Distribution

Distributed in 21 states:

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