Blood Draw and Lab Collection Kits Recalled for Potential Sterility Defect
Medline Industries is recalling blood draw and lab collection kits due to potential lack of sterility in component solutions. The affected kits could contain non-sterile solutions, posing risks in clinical procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification by the agency indicates serious risk. While no illnesses or injuries have been reported, potential lack of sterility in clinical blood draw and specimen collection solutions presents significant risk of patient harm through infection.
Plain-English summary
Medline Industries, LP is recalling certain blood draw, lab collection, and obstetric lab collection kits manufactured using specific Nurse Assist component solutions. The affected product references are: BLOOD DRAW KIT (REF DYNDV2183A), LCPH LAB DRAW KIT (REF DYNDH1641A and DYNDH1641AH), and OB LAB COLLECTION KIT (REF DYNDH1719A).
The recall was initiated due to potential lack of sterility in the component solutions, which include 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Non-sterile solutions could result from the potential sterility defect.
The affected kits were distributed nationwide across the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Identification of affected inventory is possible through product reference numbers and lot numbers: 22ABT635, 22ABY152, 22BBO850 for DYNDV2183A; 22DMB468 for DYNDH1641A and DYNDH1641AH; and 23ABC589, 23ABR972, 23BBS014 for DYNDH1719A.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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 (17)
- a) REF DYNDV2183A
- UDI/DI 40195327050710 (case)
- 10195327050719 (unit)
- Lot Numbers: 22ABT635
- 22ABY152
- 22BBO850
- b) REF DYNDH1641A
- UDI/DI 40195327003273 (case)
- 10195327006839 (unit)
- Lot Numbers: 22DMB468
- c) REF DYNDH1641AH
- d) REF DYNDH1719A
- UDI/DI40889942880486 (case)
- 10889942880485 (unit)
- Lot Numbers: 23ABC589
- 23ABR972
- 23BBS014
Distribution
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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