Avid Medical Recalls TruCustom CATH PACK Kits Due to Foreign Material
Avid Medical is recalling 444 TruCustom CATH PACK kits because they may contain loose polypropylene foreign material in the needles.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a foreign material defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Avid Medical, Inc. is recalling 444 units of AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14. The recall affects kits distributed in Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.
The recall was initiated because certain kits contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. The affected lots have expiration dates ranging from February 1, 2019, to August 1, 2019.
Consumers and healthcare facilities should stop using these kits and contact Avid Medical for further instructions or a refund.
The recalled product
- Product
- AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Catheter Kits
- Hazard
- Affected units
- 444
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 (13)
- Lot
- Expiration Date: 1190449
- 2/1/2019
- 1210124
- 6/1/2019
- 1217082
- 8/1/2019
- 1219275
- 3/1/2019
- 1221265
- 3/31/2019
- 1222551
- 7/1/2019
Distribution
Part of a larger recall action
This product is one of 23 recalled by Avid Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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