Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Reason for recall: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Om Quantity: 5308 units Lot/code info: a) DBM S44105 GRAFTON 5CC CRUNCH, REF S44105, GTIN 00613994961099, Serial Numbers: A41055, A41991; b) DBM S44115 GRAFTON 15CC CRUNCH, REF S44115, GTIN 00613994961082, Serial Numbers: A46383, A43751, A43940, A44572; c) DBM T44105 5CC GRAFTON CRUNCH, REF T44105, GTIN 00643169123120, Serial Numbers: A38507-041, A38507-042, A38507-043, A38507-044, A38507-045, A38507-046, A38507-047, A38507-048, A38507-049, A38507-050, A40379-096, A40379-097, A40379-098, A40379-099, A40379-100, A40379-101, A40379-102, A40379-103, A40379-104, A40379-105, A40379-106, A40379-107, A40379-108, A40379-109, A40379-110, A40379-111, A40379-112, A40379-113, A40379-114, A40379-115, A40379-116, A41167-031, A41167-032, A41167-033, A41167-036, A41167-037, A41167-038, A41167-039, A41167-040, A41167-041, A41167-042, A41167-043, A41167-044, A41167-045, A41167-046, A41167-047, A41167-048, A41167-049, A41167-050, A41167-051, A41167-052, A41167-053, A41167-054, A41167-055, A41167-056, A41167-057, A41167-058, A41167-059, A41167-060, A41167-061, A41167-062, A41167-063, A41167-064, A41167-065, A41167-066, A41167-067, A41167-068, A41167-070, A41169-181, A41169-182, A41169-183, A41169-184, A41169-185, A41169-186, A41169-187, A41169-189, A41169-192, A41169-193, A41169-194, A41169-195, A41169-196, A41169-197, A41169-198, A41169-199, A41169-200, A41169-201, A41169-202, A41169-203, A41169-204, A41568-135, A41568-136, A41568-137, A41568-138, A41568-139, A41568-140, A41568-141, A41568-142, A41568-143, A41568-144, A41568-145, A4
00613994961099, 00613994961082, 00643169123120, 00643169965034, 00643169123113
Official record: FDA (Device enforcement) ↗
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