Surgical convenience kits recalled for compromised external packaging sterility
Medline Industries is recalling 1,588 surgical kits nationwide due to a perforated bag design that prevents the outside of the kit wrapping from remaining sterile.
What this means for you
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: This is a Class II FDA recall involving surgical kits where packaging design prevents the outer wrapping from maintaining sterility. While no illnesses or injuries have been reported, this defect represents a risk-of-harm product in the context of surgical procedures where sterility is critical.
Plain-English summary
Medline Industries, LP is recalling three types of surgical convenience kits: the Centurion Medical Products Central Line Dressing Change Kit (Reorder Number DT21400), the Centurion Medical Products Custom Port Access Kit (Reorder Number DT22255), and the Medline CVC Dressing Change Kit (Reorder Number DYNDC1022GB). A total of 1,588 units were distributed nationwide.
The kits are being recalled because the perforated bag does not allow the outside of the kit wrapping to be sterile. As a result, only the contents inside the kit's wrapping are sterile, not the external wrapping.
Anyone who has received these kits should discontinue use and contact Medline Industries, LP for further instructions regarding the recalled units.
The recalled product
- Product
- Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-compromise
- contamination-risk
- packaging-defect
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 (6)
- a) Reorder Number DT21400
- GTIN 40653160318225 Lot # 22HMH962
- b) Reorder Number DT22255
- GTIN 40653160328644 Lot # 22HMH427
- c) Reorder Number DYNDC1022GB
- GTIN 40195327038701 Lot # 22GBY236
Distribution
Distributed nationwide across the United States.
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